MAUDE Adverse Event Report: SYNTHES GMBH 2.4/2.7MM VA-LCP BENDING PLIER; PLIERS,SURGICAL

Catalog Number	03.211.005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
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 the tip on the pilar nose is broken off.This is the tip that fits into the plate hole.There was no patient involvement.This report is for one (1) 2.4/2.7mm va-lcp bending plier.This is report 1 of 1 for complaint (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 number: 03.211.005, lot number: t105608, manufacturing site: tuttlingen, release to warehouse date: august 28, 2014, september 18, 2014.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.Visual inspection: the bend-plier f/va lockpl was received at juarez pal.Visual examination found the distal positioning pin has broken off.The broken fragment was not returned.No other product defect was identified.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection was performed due to post-manufacturing damage.Complaint relevant dimensions cannot be taken.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: the overall complaint was confirmed for the received 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.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 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: 2.4/2.7MM VA-LCP BENDING PLIER
• Common Device Name: PLIERS,SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13259012
• Report Number: 8030965-2022-00346
• Device Sequence Number: 4761299
• Product Code: HTC
• UDI-Device Identifier: 07611819434790
• UDI-Public: (01)07611819434790
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• 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 Catalogue Number: 03.211.005
• Device Lot Number: T105608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 01/28/2022; 04/06/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 02/25/2022; 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2014
• 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
• Patient Sex: Unknown