MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INNER SHAFT FOR REMOVAL SCREWDRIVER; SCREWDRIVERS

Model Number	03.647.972
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is synthes sales representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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
It was reported that on (b)(6) 2019, during testing at service and repair, the loaner department found that the tip of the inner shaft for removal screwdriver was broken.There was no patient involvement.This report is for one (1) inner shaft for removal screwdriver.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.Part: 03.647.972; lot: l194593; manufacturing site: hägendorf; release to warehouse date: july 06, 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Only top level of the device history record reviewed as sub-components are not lot tracked.Visual inspection: visual inspection performed on received device showed that the tip of the inner shaft for removal screwdriver was found broken.The received condition of the device matches with the complaint condition.Dimensional inspection: dimensional analysis was not performed as relevant features are significantly broken due to post-manufacturing damage.Document specification review: the following document were reviewed (both current and time of manufacturing) inner drive removal complete mre review: a manufacturing record evaluation (mre) was performed for the finished device lot number, and no non-conformance were identified.Only top level of the device history record reviewed as sub-components are not lot tracked.Conclusion: a definitive root cause for the device breakage could not be determine; it is possible that the device encountered unintended forces (during usage) that led to observed condition.The overall complaint condition is confirmed.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: INNER SHAFT FOR REMOVAL SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8654275
• Report Number: 2939274-2019-58375
• Device Sequence Number: 11404688
• Product Code: HXX
• UDI-Device Identifier: 10705034720807
• UDI-Public: (01)10705034720807
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2019

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: 03.647.972
• Device Catalogue Number: 03.647.972
• Device Lot Number: L194593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1