MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC THREADED HAMMER GUIDE CONNECTOR; MISC ORTHO SURGICAL INSTR

Model Number	03.037.120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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, during the cleaning process, the insertion handle was broken.It was observed while putting sets back together after they were put through wash.There was no patient involvement.This complaint involves (1) device.This report is for (1) threaded hammer guide connector.This report is 2 of 3 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.H3, h4, h6: part # 03.037.120.Lot # 9723770.Release to warehouse date: 11 dec 2015.Supplier: selzach.Manufacturer: hagendorf.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Photo investigation: the complaint devices were not returned for investigation.A photo investigation was completed using the images.In the images, it could be seen that a threaded portion of the driving cap had broken and was left inside the connector-handle assembly.Due to this, it would have been difficult to separate the connector from the handle.Other than this, the threaded hammer guide connector did not have any observable issue.Therefore, the complaint against the connector could not be confirmed.Document/specification review was not performed as no defect could be identified on this device based on the photographs.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition cannot be confirmed based on the images during photo investigation.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.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: THREADED HAMMER GUIDE CONNECTOR
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12249657
• Report Number: 2939274-2021-04331
• Device Sequence Number: 2885425
• Product Code: LXH
• UDI-Device Identifier: 10886982070586
• UDI-Public: (01)10886982070586
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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: 03.037.120
• Device Catalogue Number: 03.037.120
• Device Lot Number: 9723770
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 08/24/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COMPLETE RADIOLUCENT INSERTION HANDLE; DRIVING CAP/THREADED