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 Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a j&j sales representative.The device has been 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 an unknown date, the two (2) screwdriver blades for 90 degree screwdriver was falling out during routine testing.There was no patient involvement.This report is for one (1) matrixrib screwdriver blade self-retaining f/90° scrwdrvr.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Product complaint (b)(4).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.D11: concomitant devices reported.H3, h4, h6: device history lot: part # 03.501.750.Synthes lot # u258392.Supplier lot # u258392.Release to warehouse date: 24 jan 2017.Supplier: orchid unique.No ncr's were generated during production.Device history batch null, device history review the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Investigation summary background: it was reported that on an unknown date, the screwdriver blades for 90 degree screwdriver was falling out during routine testing.There was no patient involvement.This complaint involves one (2) device.H6: investigation flow: device interaction.Visual inspection: matrixrib screwdriver blade self-retaining f/90° scrwdrvr (part# 03.501.750, lot# u258392, qty# 1) was returned and received at us cq.Upon visual inspection at cq, it is observed that the proximal prongs of the blade got deformed.The rest of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.Functional testing: functional testing of the received device was not performed at cq as the device was received by itself.But the deformed prongs might have contributed to the reported unable to assemble complaint condition can the complaint be replicated with the returned device(s)? unable to perform.Dimensional inspection: dimensional inspection of the returned device was not performed at cq due to post manufacturing damage.Document/ specification review: the following drawings were reviewed during the investigation: self retaining screwdriver blade for 90 degree screwdriver: 03_501_750 rev.C no design issues or discrepancies were noticed.Complaint was confirmed.Investigation conclusion: the complaint condition was confirmed for the matrixrib screwdriver blade self-retaining f/90° scrwdrvr (part# 03.501.750, lot# u258392).While a definitive root cause for the reported problem cannot be determined, it is possible that the prongs of the device might have encountered unintended forces.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues, or discrepancies were observed that may have contributed to the complaint condition.Based upon these results, 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.Therefore, it has been determined that no corrective and/or preventive action is proposed.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: 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: 11224274
• Report Number: 2939274-2021-00447
• Device Sequence Number: 11821952
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2021

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
• Device Lot Number: U258392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Initial Date Received by Manufacturer: 01/03/2021
• Supplement Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MATRIXRIB SCRDRVR BLD SLF-RETAIN F/90° SCRWDRVR.; MATRIXRIB SCRDRVR BLD SLF-RETAIN F/90° SCRWDRVR.