MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET

Catalog Number	399.124
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, reduction forceps broke while reducing a fracture and holding a plate.There was no patient involvement.The outcome of the procedure was not reported.Concomitant device reported: unk - plate: (part# unknown; lot# unknown; quantity: unknown).This report is for one (1) reduction forceps w/serrated jaw-large handle-soft ratchet.This is report 1 of 1 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.H11 corrected data: d4: lot number updated.H4: manufacturing date updated.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.Visual inspection: the reduc-forceps toothed softlo l250 (part #: 399.124, supplier lot #: 5016029, synthes lot #: 5609784) was received at us cq.Upon visual inspection, it was observed that the left jaw tip of the complaint device had broken off.The broken off jaw was received at us cq.Additionally, rust was observed at the breaking point of the left jaw tip.No other issues were identified.The image(s) provided in the attachment(s) were reviewed.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage and device geometry.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint was confirmed for the reduc-forceps toothed softlo l250 (part #: 399.124, supplier lot #: 5016029, synthes lot #: 5609784) as the left jaw tip of the complaint device had broken off.Additionally, rust was observed at the breaking point of the left jaw tip.While no definitive root cause could be determined, it is possible that the device encountered unintended forces during use.No new, unique or different patient harms were identified as a result of this evaluation.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 part #: 399.124, synthes lot number: 5609784, supplier lot #: 5016029, release to warehouse date: 01-oct-2007, supplier: (b)(4), the raw material was confirmed to be correct per the specification with no (relevant) non-conformance noted.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.
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.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided in the attachment(s).The image(s) was reviewed, and the complaint condition could be confirmed as one of the jaws of the reduc-forceps toothed softlo l250 was found to be broken.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A manufacturing record evaluation was performed.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 images) 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 preventative action is proposed.Device history part number: 399.124, lot number: 5016029, manufacturing site: unknown, release to warehouse date: unknown.Part/lot combination are unknown at synthes tuttlingen gmbh, no dhr review possible.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: REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET
• Common Device Name: FORCEPS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10227606
• Report Number: 8030965-2020-04627
• Device Sequence Number: 10911376
• Product Code: HTD
• UDI-Device Identifier: 07611819221048
• UDI-Public: (01)07611819221048
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/20/2020

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 Catalogue Number: 399.124
• Device Lot Number: 5609784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Received by Manufacturer: 06/20/2020
• Supplement Date Received by Manufacturer: 07/17/2020; 08/27/2020; 09/15/2020; 09/16/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 08/05/2020; 09/02/2020; 09/15/2020; 09/17/2020
• 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: UNK - PLATES