MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RATCHETING HANDLE WITH QUICK COUPLING; MISC ORTHO SURGICAL INSTR

Model Number	03.100.032
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: event year is reported as 2021; however exact date of event is unknown.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Initial 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 that on unknown date, products found broken after surgery and are beyond repair.No further information is available.This complaint involves eighteen (18) devices.This report is for (1) ratcheting handle with quick coupling.This report is 7 of 14 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, h4, h6- the reported condition of the complaint device (ratcheting handle with quick coupling) is confirmed.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 # 03.100.032; synthes lot # 5887560; supplier lot # 595531h08; release to warehouse date: 26 sep 2008; supplier: (b)(4); no ncr's were generated during production.Device history batch: null.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.
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, h6: the device was received, the investigation is in progress, 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.

• Brand Name: RATCHETING HANDLE WITH QUICK COUPLING
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13196426
• Report Number: 2939274-2022-00070
• Device Sequence Number: 5983909
• Product Code: LXH
• UDI-Device Identifier: 10886982070814
• UDI-Public: (01)10886982070814
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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: 03.100.032
• Device Catalogue Number: 03.100.032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 02/04/2022; 02/10/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 02/08/2022; 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0MM FLEXIBLE SHAFT; 5.0MM FLEXIBLE SHAFT; 5.0MM FLEXIBLE SHAFT; 5.0MM FLEXIBLE SHAFT 620MM; DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T; DPTH GUGE FOR 2.7MM & SML SCRWS; GRPC CASE FOR 3.5/4.0MM CMBND CANULD SCRW SET; GRPHIC CSE FOR 3.5/4.0MM COMBND CANNLTED SCRW SET; HELICAL BLADE/SCREW COUPLING SCREW; HOLD-FORCEPS F/SYNREAM REAMING ROD Ø2.5; HOLDSLEEVE W/WINGSCR L105 I-Ø 6 F/LARGE-; LARGE QUICK COUPLING; RATCHET WRENCH-11MM WIDTH ACROSS FLATS; SM FRG LCP INST & IMPL SET GRPIC CASE; SOCKET WRENCH-11MM WIDTH ACROSS FLATS; UNIVERSAL CHUCK WITH T-HANDLE; UNIVERSAL CHUCK WITH T-HANDLE
• Patient Sex: Unknown