MAUDE Adverse Event Report: SYNTHES GMBH BENDING TEMPLATE FOR 3.5MM LOW PROFILE RECON J-PL/16 HOLES

Catalog Number	03.100.035
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
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.E1: initial reporter is j&j company representative.H3, h4, h6 investigation summary: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that bend-templ f/lowprofile3.5 reco-j-pl 16h was broken across the four hole, the broken surface was observed to be bent in both direction.Fragment was received for evaluation.No other issues were identified.Per the pelvic implants and instruments surgical technique guide precautions: 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-templ f/lowprofile3.5 reco-j-pl 16h was not 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 synthes 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 reco-j-pl 16h would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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.Dimensional inspection: n/a.Device history a manufacturing record evaluation was performed for the finished device product code:03.100.035.Lot no:2349p25.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 13-jan-2023.Manufacturing site: jabil bettlach.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 that on (b)(6) 2024, the patient underwent an orif surgery for a fracture of the right coxal bone.The template broke off in the 4th hole from proximal.(03.100.035).The surgery was completed successfully with no surgical delay.Patient was listed as stable.This report is for one bending template for 3.5mm low profile recon j-pl/16 holes for (b)(4).

• Brand Name: BENDING TEMPLATE FOR 3.5MM LOW PROFILE RECON J-PL/16 HOLES
• Common Device Name: TEMPLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): JABIL BETTLACH; muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19268011
• Report Number: 8030965-2024-05968
• Device Sequence Number: 17891704
• Product Code: HWT
• UDI-Device Identifier: 10886982070845
• UDI-Public: (01)10886982070845
• 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: 03.100.035
• Device Lot Number: 2349P25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - PLATES: TRAUMA
• Patient Sex: Unknown