SYNMESH® 17MM X 22MM 26MM HEIGHT (TI)
Received Nov 9, 2015 · Event occurred Mar 22, 2012
Report 3003506883-2015-10168 · MDR key 5209880
Device
Product problems
- Incorrect Device Or Component Shipped
- Packaging Problem
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
DHR REVIEW ¿ PART MFG DATE: 05/26/2011. PART EXP. DATE: N/A (FOR S PART NUMBERS). DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF SYNMESH 17MM X 22MM 26MM HEIGHT TI IMPLATES WERE PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NON-CONFORMANCES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE REVIEW OF THE RAW MATERIAL VENDOR MACHINED BLANK REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCE NOTED. THE REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCE NOTED. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THERE ARE NO ISSUES IDENTIFIED IN THE DHR THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION AND NO PRODUCT HAS BEEN RETURNED, THEREFORE THE COMPLAINT IS UNCONFIRMED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Additional Manufacturer Narrative
NO REPORTED PATIENT INVOLVEMENT. UNKNOWN WHEN COMPLAINANT EVENT OCCURRED, COMPLAINANT EVENT DISCOVERED ON (B)(6) 2012. DEVICE WAS RETURNED, THEREFORE NOT IMPLANTED / EXPLANTED. THIS FILE WAS IDENTIFIED UNDER AN MDR DETERMINATION RETROSPECTIVE EVALUATION, TO REVIEW COMPLAINT RECORDS AS POTENTIAL REPORTABLE EVENTS. THIS COMPLAINT FILE SHOULD HAVE BEEN A PART OF THIS REVIEW AND HAS SINCE BEEN PUT INTO THE COMPLAINT MANAGEMENT SYSTEM FOR REPORTABILITY DETERMINATION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A PACKAGE WAS RECEIVED WITH THE WRONG IMPLANT CONTAINED IN THE PACKAGE. THIS IS REPORT 2 OF 2 FOR (B)(4).