MAUDE Adverse Event Report: SYNTHES GMBH BEND-TEMPL F/LOWPROFILE3.5 RECOPL-CURVED; TEMPLATE

Catalog Number	03.100.037
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthese reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent the open reduction internal fixation with the bending template for the pelvic fracture.The bending template in question broke in the middle of bending and applying it.The surgery was completed successfully with r88 template and plate without any surgical delay.According to the surgeon, the bending template might have been overused and deteriorating.It was confirmed by the image intensifier that there were no fragments in the patient¿s body.The surgeon also commented that he did not understand why the template has 16 holes, but the implants only have up to 14 holes.No further information is available.This report is for one (1) bend-templ f/lowprofile3.5 recopl-curved this is report 1 of 1 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: (b)(6) part #: 03.100.037 lot #: 32p2785 manufacturing site: jabil bettlach release to warehouse date: (b)(6) 2020 a manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.The product was returned to depuy synthese for evaluation.The depuy synthese team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the bend-templ f/lowprofile3.5 recopl-curved was found broken in two pieces.While a root cause cannot be determined for the reported issue, it is possible that the plate was bent in an inappropriate direction leading to the breakage.Additionally other bending marks can be observed in different section of the returned sample.The pelvic implants and instruments surgical technique was reviewed.Following statement was found: precaution: reverse bending or use of the incorrect instrumentation for bending may weaken the plate and lead to premature plate failure (e.G.Breakage).Do not bend the plate beyond what is required to match the anatomy.A dimensional inspection for the bend-temp f/lowprofile3.5 recopl-curved was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthese quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the bend-templ f/lowprofile3.5 recopl-curved would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Drawing/specifications reviewed: the following drawings reflecting the current and manufactured revisions were reviewed: rev.G (current) / rev.F (manufactured) dimensional inspection: n/a 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: BEND-TEMPL F/LOWPROFILE3.5 RECOPL-CURVED
• Common Device Name: TEMPLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 16396304
• Report Number: 8030965-2023-01981
• Device Sequence Number: 15046820
• Product Code: HWT
• UDI-Device Identifier: 07611819796805
• UDI-Public: (01)07611819796805
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 03.100.037
• Device Lot Number: 32P2785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2020
• 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
• Patient Sex: Unknown