MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MATRIXRIB SCREWDRIVER BLADE SELF-RETAINING F/90 SCRWDRVR

Model Number	03.501.750
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary.Investigation flow: visual.Visual inspection: the matrixrib screwdriver blade self-retaining f/90° screwdriver (product code: 03.501.750 & lot no: unknown) was received at us cq.The visual inspection of the received device indicated that there are numerous dings on the driver and the blade end along with various cosmetic non-conformances along the length of the part.All these signs are indicative of a part that has been used numerous times.The worn condition of the compliant device is consistent as an end of the life indicator for the device.The alleged device interaction issue may be caused due to the device worn condition.Due to the worn condition, the complaint can be confirmed as the device is now inoperable.Conclusion: after a visual inspection per guidance provided in windchill document, it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.The lot number is unknown and the possible root cause for this issue is not related to the manufacturing, therefore a manufacturing record evaluation is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: the possible root cause for this issue is not related to manufacturing, therefore a manufacturing record evaluation is not required.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) 2020, the shaft for 90° screwdriver would strip out/not turn screw when tested.There was no patient involvement.This complaint involves twenty-five (25) devices.This report is for (1) matrixrib screwdriver blade self-retaining f/90° screwdriver.This is report 3 of 3 for (b)(4).Related product complaint: (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.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
This is report 5 of 5 for (b)(4).

• Brand Name: MATRIXRIB SCREWDRIVER BLADE SELF-RETAINING F/90 SCRWDRVR
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10712609
• Report Number: 2939274-2020-04753
• Device Sequence Number: 17070959
• Product Code: HXX
• UDI-Device Identifier: 10887587011424
• UDI-Public: (01)10887587011424
• Combination Product (Y/N): N
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

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: 03.501.750
• Device Catalogue Number: 03.501.750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1