TC RYDER NEEDLE HOLDERDELSERR 265MM

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH BM047R - TC RYDER NEEDLE HOLDERDELSERR 265MM VIA INFORMATION RECEIVED FROM A MEDSUN REPORT. SPECIFICALLY, IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE ONE SIDE OF THE JAW OF THE NEEDLE HOLDER WAS MISSING. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT´S MITRAL VALVE. NO ADVERSE CONSEQUENCES FOR THE PATIENT WERE REPORTED. THIS MEDWATCH IS BEING SENT AS A FEEDBACK TO THE FDA IN REFERENCE TO THE MEDSUN REPORT: (B)(4). ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3 AND 803.50, THIS EVENT IS NOT CONSIDERED / DEEMED AS A REPORTABLE EVENT FOR THE FOLLOWING REASON: NO DEATH OR SERIOUS INJURY NO MALFUNCTION THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, IF THE MALFUNCTION WERE TO RECUR. ADDITIONAL INFORMATION WAS NOT PROVIDED BUT HAS BEEN REQUESTED. THE EVENT IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H6: CODES UPDATED. INVESTIGATION RESULTS: THE COMPLAINED MEDICAL DEVICE WAS NOT MADE AVAILABLE FOR INVESTIGATION. THE INVESTIGATION WAS BASED UPON HISTORICAL DATA ANALYSIS, EVENT DESCRIPTION AND REVIEW OF A PICTURE PROVIDED BY THE HEALTHCARE FACILITY. THE PROVIDED PICTURE SHOWS THAT THE CARBIDE INSERT HAS BROKEN OUT, AS A GAP IS VISIBLE AT THE WORKING END. DUE TO THE FACT THAT NO LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE COMPLAINED MEDICAL DEVICE IS NOT POSSIBLE. EVEN AFTER FAITHFUL ATTEMPTS FOR RETRIEVAL, NO FURTHER INFORMATION COULD BE RECEIVED. CONCLUSION/PREVENTIVE MEASURES: ON THE BASIS OF THE CURRENT INFORMATION AND WITHOUT THE COMPLAINED MEDICAL DEVICE BEING AVAILABLE FOR INVESTIGATION, A CLEAR ROOT CAUSE CANNOT BE DRAWN. IN THE EVENT THAT THE COMPLAINED MEDICAL DEVICE WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON INVESTIGATION RESULTS, A CAPA IS NOT REQUIRED. FINAL COMMENTS: THIS MEDWATCH IS BEING SENT AS A FEEDBACK TO THE FDA IN REFERENCE TO THE MEDWATCH: (B)(4). ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3 AND 803.50, THIS EVENT IS NOT CONSIDERED / DEEMED AS A REPORTABLE EVENT FOR THE FOLLOWING REASON: NO DEATH OR SERIOUS INJURY, NO MALFUNCTION THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, IF THE MALFUNCTION WERE TO RECUR.