MAUDE Adverse Event Report: SYNTHES GMBH SYNPOR SHEET 50*50 T0.8; MESH, SURGICAL, POLYMERIC

Catalog Number	08.510.120S
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
J&j medtech is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which j&j medtech has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, j&j medtech or its employees that the report constitutes an admission that the device, j&j medtech, or its employees caused or contributed to the potential event described in this report.Investigation summary the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned sample found the implant was returned with it's opened packaging.Evidence of manipulation was observed; the implant was segmented in three fragments.A dimensional inspection was performed to the thickness of the implant sheet and met specifications.Even though bent condition was not observed, with evidence provided the reported condition can be confirmed.Synpor sheet with product code 08.510.120s is not provided with a thin layer of solid polyethylene that may provide a thicker appearance.Variety of implant porous sheets sizes and thickness are available to adjust surgical procedure necessities.Additionally, two mall fragments were also found separated apart, and not returned for analysis.This observed condition of the device was consistent with a component failure that was caused by exposure to unintended forces.Surgical technique was reviewed and the following relevant statement was found at page 5: synpor sheets implants have an open interconnected porosity to support tissue ingrowth.Synpor smooth sheets implants have a thin layer of solid polyethylene on the superior surface and porous polyethylene on the inferior surface.Implants are provided in a variety of shapes and thicknesses with access to definitive contouring.For smooth implants, place the smooth side of the implant toward the soft tissue.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 synpor sheet 50*50 t0.8 would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics 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.Dimensional inspection: feature: porous sheet thickness, specification: 0.80 +/- 0.2 mm, measured dimension: 0.894 mm (conforming).Device history product code: 08.510.120s, lot number : ds7009057, release to warehouse date : 01.Mar.2022, expiration date : 01.Feb.2027, supplier: (b)(4).Manufacturing site: werk selzach.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 during the surgery, opened the packing, the device was found to be too soft and unsupported(as the attached video shows).Another device was used to complete the surgery.There were no adverse consequences to the patient.No surgical delay.

• Common Device Name: MESH, SURGICAL, POLYMERIC
• 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 ; 9083863534
• MDR Report Key: 22168885
• Report Number: 8030965-2025-05746
• Device Sequence Number: 18097366
• Product Code: FTL
• UDI-Device Identifier: 10887587026039
• UDI-Public: (01)10887587026039(17)270201(10)DS7009057
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051879
• 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
• Report Date (Section B): 06/09/2025

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: 08.510.120S
• Device Lot Number: DS7009057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 60 KG