MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC . BALL HEX SCREWDRIVER 8MM . FOR TI FEMORAL NAILS; SCREWDRIVERS

Model Number	357.515
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: synthes employee.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that fat came out of the phenolic handle after sterilization within the company recommendation (cleaning ph, and sterilization t).It was unknown that it happened during sterilization or field inspection.There were no patient consequences.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual inspection: the scr-driver-hex w/spheric-head ø8 (part # 357.515, lot 5373996, mfg 07-nov-2006) was received at us cq with some evidence of a greasy substance on the handle.The substance cannot be confirmed as fat at us cq.However, the complaint is confirmed since there is some greasy unidentified substance on the handle.Document/specification review: the following drawing(s) was reviewed; ball hex screwdriver, 8 mm for ti femoral nails.A manufacturing record evaluation cannot be completed since the lot number is unknown.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device may have absorbed some substance during surgery.No new malfunctions were observed during the course of this investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history part # 357.515, synthes lot # 5373996, supplier lot # na, release to warehouse date: 07 nov 2006 , manufactured by synthes brandywine, no ncr's were generated during production.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.

• Brand Name: . BALL HEX SCREWDRIVER 8MM . FOR TI FEMORAL NAILS
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9330865
• Report Number: 2939274-2019-62249
• Device Sequence Number: 2588196
• Product Code: HXX
• UDI-Device Identifier: 10886982196514
• UDI-Public: (01)10886982196514
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 357.515
• Device Catalogue Number: 357.515
• Device Lot Number: 5373996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1