MAUDE Adverse Event Report: Synthes GmbH BENDING TEMPLATE FOR 3.5MM LP CRVD RECON PL-88MM RAD/16H

Catalog Number	03.100.036
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when molding the template to determine the required plate length, it fractured.The specialist was not bothered, and the procedure was not delayed, as the surgery was successfully completed using another template.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11.Additional manufacturer narrative: h3, h6: a manufacturing record evaluation was performed for the finished device product code: 03.100.036 lot number: 5367p52 it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 31 mar 2023 manufacturing site: jabil bettlach the photo investigation revealed the plate was broken.The broken fragments can be observed in the photo evidence.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the bend-templ f/lowprofile3.5 recopl-curved was broken, scratched and cracked.The observed condition of the device is consistent with a component failure that was caused by exposure to unintended forces, such as overtightening the device while molding.Properly handling and attention to the approved use of the device diminish the risk of failure.According to the pelvic implants and instruments surgical technique guide the following warnings are mentioned: do not bend the plate at the level of the holes.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 was unable to be performed due to the post-manufacturing damage.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the bend-templ f/lowprofile3.5 recopl-curved would have contributed to the complained device issue was consistent with the reported condition.Based on the investigation findings, the potential cause is traced to overtightening the device while molding.There is no indication that a design or manufacturing issue has caused the reported complaint condition and it has been determined that no corrective and/or preventative action is proposed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: BENDING TEMPLATE FOR 3.5MM LP CRVD RECON PL-88MM RAD/16H
• Common Device Name: Template
• Manufacturer (Section D): Synthes GmbH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): Monument; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50130588
• Report Number: 8030965-2026-07946
• Device Sequence Number: 17551976
• Product Code: HWT
• UDI-Device Identifier: 10886982070852
• UDI-Public: (01)10886982070852(10)5367P52
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• 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: 03.100.036
• Device Lot Number: 5367P52
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/30/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2023
• 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