DURAHOOK 1/4 HOOK 10 PKG/BX 6 HKS/PKG

Additional Manufacturer Narrative

(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

Description of Event or Problem

IT WAS REPORTED THAT THE ELASTIC SEEMS TO BE BRITTLE AND/OR BREAKING. THERE WAS NO REPORTED PATIENT INJURY.

Additional Manufacturer Narrative

(B)(4). PER DHR THE PRODUCT DURAHOOK 1/4 HOOK 10 PKG/BX 6 HKS/PKG # 73F1700330 WAS MANUFACTURED ON 06/26/2017 A TOTAL OF 1,800 PIECES. LOT WAS RELEASED ON 07/01/2017. DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO COMPLAINT. THE CUSTOMER RETURNED TWO REPRESENTATIVE SAMPLES OF 382800 DURAHOOK 1/4 HOOK 10 PKG/BOX 6 HKS/PKG FOR INVESTIGATION. THE ACTUAL SAMPLE WAS NOT RETURNED. THE RETURNED SAMPLES WERE VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION REVEALED THAT THERE ARE MULTIPLE BANDS IN EACH SAMPLE THAT SHOWED SIGNS OF DISCOLORATION. THE DISCOLORATION OF THE BANDS IS A SIGN THAT THE BANDS HAD OVER-EXPOSURE TO HEAT AND/OR UV LIGHTING. REFERENCE FILE (B)(4) FOR INVESTIGATION PHOTOS. A FUNCTIONAL TEST WAS CONDUCTED TO TEST THE DURABILITY OF THE RETURNED SAMPLES. THREE DURAHOOKS WERE TESTED FROM EACH SAMPLE, TOTALING SIX DURAHOOKS THAT WERE TESTED. THE DURAHOOK WAS ATTACHED TO A FORCE GAUGE VIA THE THERMOPLASTIC ELASTOMETRIC (TPE) BAND AND STRETCHED TO MEASURE THE AMOUNT OF FORCE ON THE BAND. THE TESTED DURAHOOKS YIELDED THE FOLLOWING RESULTS: OTHER REMARKS: 1ST TPE BAND: 3.11 LB-FORCE WITHOUT SNAPPING 2ND TPE BAND: 3.21 LB-FORCE WITHOUT SNAPPING 3RD TPE BAND: 3.38 LB-FORCE WITHOUT SNAPPING 4TH TPE BAND: 3.27 LB-FORCE WITHOUT SNAPPING 5TH TPE BAND: 3.26 LB-FORCE WITHOUT SNAPPING 6TH TPE BAND: 3.14 LB-FORCE WITHOUT SNAPPING NONE OF THE TESTED SAMPLES BROKE. ACCORDING TO DHF D001915, "THE BAND SHALL BE ABLE TO STRETCH TO AT LEAST DOUBLE OR 200% ITS ORIGINAL LENGTH WITH A FORCE OF 0.79 ¿ 0.15 LB-FORCE" AND "AT LEAST TRIPLE OR 300% ITS ORIGINAL LENGTH WITH A FORCE OF 0.90 ¿ 0.17 WITHOUT BREAKING." ALL SIX SAMPLES THAT WERE TESTED WERE ABLE TO WITHSTAND AT LEAST 3.11 LB-FORCE WITHOUT BREAKING WHICH FAR EXCEEDS THE REQUIREMENT. NO FUNCTIONAL ISSUES WERE FOUND WITH THE RETURNED SAMPLES. REFERENCE FILE (B)(4) FOR INVESTIGATION PHOTOS. SPECIFICATIONS PER GRAPHIC 14-2-001470 REV. 01 AND THE DHF FOR THIS PRODUCT, D001915 REV. 03, WERE REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME SINCE NO FUNCTIONAL DEFECTS WERE FOUND WITH THE RETURNED SAMPLES. TWO REPRESENTATIVE SAMPLES WERE RETURNED. THE ACTUAL SAMPLE WAS NOT RETURNED. THE REPORTED COMPLAINT OF "BRITTLE/BREAKING" WAS NOT CONFIRMED BASED UPON THE SAMPLES RECEIVED. TWO REPRESENTATIVE SAMPLES WERE RETURNED, BUT THE ACTUAL SAMPLE WAS NOT. MULTIPLE BANDS IN EACH SAMPLE SHOWED SIGNS OF DISCOLORATION WHICH INDICATES THAT THE SAMPLES WERE OVER-EXPOSED TO HEAT AND/OR UV LIGHTING. A FUNCTIONAL TEST WAS CONDUCTED TO TEST THE DURABILITY OF THE RETURNED SAMPLES. THE STRENGTH OF THE TPE BAND WAS TESTED VERSUS THE DESIGN SPEC AND ALL TESTED SAMPLES FAR EXCEEDED THE REQUIREMENT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE DEVICE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THERE WERE NO FUNCTIONAL ISSUES FOUND WITH THE RETURNED DURAHOOKS. SINCE ONLY REPRESENTATIVE SAMPLES WERE RETURNED, THE ROOT CAUSE OF THIS COMPLAINT ISSUE COULD NOT BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED THAT THE ELASTIC SEEMS TO BE BRITTLE AND/OR BREAKING. THERE WAS NO REPORTED PATIENT INJURY.