MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.6 COMP WIRE 30 THREAD/150 LENGTH; INSTRUMENT, COMPRESSION

Model Number	03.211.430
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 torque limiting attachment was not restrain and threaded reduction wire broke off at olive.Surgical procedure was delayed for 2 minutes.This report is for one (1) 1.6 comp wire 30 thread/150 length.This is report 1 of 1 for 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.H6: customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the photos provided.The picture was reviewed, and the complaint condition could not be confirmed since the picture did not show the broken wire.The imaged provided depicted two screw heads sticking out from an incision near the ankle.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.Document/specification review.As the lot number was unknown, the manufacturing drawing cannot be reviewed therefore only the current drawing will be reviewed.Current drawing was reviewed and no design issues or discrepancies were identified.Conclusion: the subject complaint could not be confirmed.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the picture) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, 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.
Event or Problem Description
It was reported that on (b)(6) 2021 that the torque limiting attachment would not limiting and the threaded reduction wire broke off at the olive.Pliers were used to remove the wire and the surgical procedure was delayed for two (2) minutes.
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: 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.D4.

• Brand Name: 1.6 COMP WIRE 30 THREAD/150 LENGTH
• Common Device Name: INSTRUMENT, COMPRESSION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11612707
• Report Number: 2939274-2021-01664
• Device Sequence Number: 3196572
• Product Code: HWN
• UDI-Device Identifier: 10886982076366
• UDI-Public: (01)10886982076366
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 03/08/2021

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: 03.211.430
• Device Catalogue Number: 03.211.430
• Device Lot Number: 2831
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/08/2021; 09/03/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 04/09/2021; 09/03/2021
• 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: TORQUE LIMITING ATTACHMENT 1.2NM; TORQUE LIMITING ATTACHMENT 1.2NM