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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Reporter is a j&j representative.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 on (b)(6) 2021, the threaded hammer guide connector and driving cap/threaded were noticed broken after surgery.There was no patient involvement.This complaint involves two (2) devices.This report is for (1)threaded hammer guide connector.This report is 2 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.H3, h4, h6: part: 03.037.120-us, lot: 9229527, manufacturing site: hagendorf, release to warehouse date: 11 december 2014.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the threaded hammer guide connector (part.No: 03.037.120, lot.No: 9229527, qty: 1) was returned and received at us customer quality (cq).Visual inspection of the complaint device showed no damage.The device shows only light surface wear consistent with use and which would not impact the functionality.Device failure/defect identified? no.Complaint confirmed? no.Investigation conclusion: this complaint is not confirmed as no defects were identified with the complaint device.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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: 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: 12267353
• Report Number: 2939274-2021-04460
• Device Sequence Number: 11883649
• Product Code: LXH
• UDI-Device Identifier: 10886982070586
• UDI-Public: (01)10886982070586
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 07/06/2021

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: 9229527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 08/26/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRIVING CAP/THREADED; DRIVING CAP/THREADED