MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE WITH QUICK COUPLING, SMALL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	311.43.99
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.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 small handle with quick coupling broke during fixing the radius fracture to the patient.When the surgeon was putting the final lag screw in, he applied a lot of force on it and the handle crumbled and broke inside of his hand.Several pieces like 5 or 6 were all retrieved to the patient.All of the fragments of the handle were removed from the patient and it only caused a one (1) minute surgical delay and procedure was completed successfully.Patient status is unknown.Concomitant device reported: unknown screws: lag (part# unknown, lot# unknown, quantity# 1).This report is for 1 handle with quick coupling, small.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.Investigation flow: damage.Visual inspection: the handle with quick coupling, small (p/n: 311.43.99, lot number: 4907418) was received at us cq.Upon visual inspection, it was noticed that the handle component is broken off.Device failure/defect identified: yes.Dimensional inspection: dimensional inspection cannot be performed due to post manufacturing defect.Document/ specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: the overall complaint was confirmed for the handle with quick coupling, small (p/n: 311.43.99, lot number: 4907418) as the device was broken at the handle component.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 history lot: part #: 311.43.99, synthes lot number: 4907418, manufacturing site: synthes brandywine, release to warehouse date: dec 13, 2004.The raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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: HANDLE WITH QUICK COUPLING, SMALL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9986146
• Report Number: 2939274-2020-01984
• Device Sequence Number: 3700533
• Product Code: LXH
• UDI-Device Identifier: 10705034768717
• UDI-Public: (01)10705034768717
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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: 311.43.99
• Device Catalogue Number: 311.43.99
• Device Lot Number: 4907418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 05/07/2020
• 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: UNK - SCREWS: LAG; UNK - SCREWS: LAG
• Patient Age: 22 YR