MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANN CONNECTING SCR F/PERCUTAN INSTS NL; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.010.404
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: complainant device/part received.Initial reporter is j&j company representative the investigation could not be completed; no conclusion could be drawn.A review of the device history records has been requested.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) 2021, the insertion handle and connecting screw are not aligning and connecting to the nail correctly.Send for a second suprapatellar set from the other level one facility.The procedure was successfully completed with a thirty minutes surgical delay.No patient consequence.Concomitant devices reported: unknown nail (part# unknown, lot# unknown, quantity 1) this complaint involves two (2) devices.This report is for one (1) cann connecting scr f/percutan insts nl.This report is 1 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: part # 03.010.404, synthes lot # u217593, supplier lot # u217593, release to warehouse date: 16 apr 2015, supplier: orchid unique a nonconformance was.Generated due to pin gage did not pass thru and to check dimension.Scar was issued, inspection sheet was changed and it was determined all parts conform and no risk to patient.All parts at distributor conform and no patient risk.Relevance to complaint condition cannot be determined until the product is returned for investigation.Review of the device history record(s) showed that there are potential issues during the manufacture of the product that would contribute to this complaint condition.Visual inspection: the cann connecting scr f/percutan insts nl (p/n: 03.010.404, lot #: u217593) was returned and received at us customer quality (cq).Upon visual inspection, there were scratches on the device but have no impact on the device functionality.No other issues were observed with the returned device.Functional test: a functional test was not performed as all mating devices were not returned.Can the complaint be replicated with the returned device? unable to perform.Dimensional inspection: specified dimensions: shaft diameter mm measured dimensions: shaft diameter = confirming.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.-cannulated connecting screw.Complaint confirmed? no.Investigation conclusion: the complaint condition was not confirmed for the cann connecting scr f/percutan insts nl (p/n: 03.010.404, lot #: u217593).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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: CANN CONNECTING SCR F/PERCUTAN INSTS NL
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11866715
• Report Number: 2939274-2021-02506
• Device Sequence Number: 1099690
• Product Code: FZX
• UDI-Device Identifier: 10886982068569
• UDI-Public: (01)10886982068569
• Combination Product (Y/N): N
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2021

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: 03.010.404
• Device Catalogue Number: 03.010.404
• Device Lot Number: U217593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Initial Date Received by Manufacturer: 04/25/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 06/16/2021
• 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: INSERTION HANDLE FOR SUPRAPATELLAR; UNK - NAILS
• Patient Age: 36 YR