MAUDE Adverse Event Report: SYNTHES GMBH REDUCTION FORCEPS WITH POINTS BROAD-RATCHET

Model Number	398.41
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown day in march 2023, the instruments were found broken or damaged.There was no patient consequence.No further information is available.This report involves one reduction forceps with points broad-ratchet.This is report 1 of 3 for pc - (b)(4).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Only the event year and month are known.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.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.
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.D10.Therapy dates: (b)(6) 2023.Part number: 398.41.Lot number: t201088.Manufacturing site: tuttlingen.Release to warehouse date: 07-oct-2020.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.Product was not returned.Based on the information available, it has been determined that no corrective and preventative 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.
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: h4.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 march 1, 2023, that.There was no patient involvement.

• Brand Name: REDUCTION FORCEPS WITH POINTS BROAD-RATCHET
• Common Device Name: FORCEPS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16656128
• Report Number: 8030965-2023-03927
• Device Sequence Number: 14970361
• Product Code: HTD
• UDI-Device Identifier: 10886982201386
• UDI-Public: (01)10886982201386
• 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: Health Professional,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: 398.41
• Device Catalogue Number: 398.41
• Device Lot Number: T201088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 04/05/2023; 05/01/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 04/21/2023; 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRIVING CAP; MONOBLOC FLEXIBLE REAMER 13.5 - STD - DD; MONOBLOC FLEXIBLE REAMER 14.5 - STD - DD; MONOBLOC FLEXIBLE REAMER 15.5 - STD - DD; REDUCTION FORCEPS EXTRA SMALL 140MM AWSL; SHARP HOOK; TFNA OPENING TRAY
• Patient Sex: Unknown