MAUDE Adverse Event Report: SYNTHES GMBH SYNPOR SQUARE SHEET-SILE 50X50/0.8 THICK; MESH, SURGICAL, POLYMERIC

Catalog Number	08.510.120S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Additional narrative: h3, h6: part: 08.510.120s lot: ds7009059 manufacturing site: werk selzach logistik.Release to warehouse date: 01 march 2022.Expiration date: 01 february 2027.Supplier: dsm biomedical.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.The product was not returned to j&j medtech orthopaedics; however, photos were received for review.The photo investigation revealed that the synpor square sheet-sile 50x50/0.8 thick was broken/delamination in one of the corners and at some specific points along the sheet.Therefore, the complaint condition can be confirmed.According to synpor porous polyethylene implant surgical technique, the following precautions and warnings are indicated.Precautions: excessive and repetitive contouring of the implant increases the risk of implant breakage.In order to determine the appropriate amount of fixation for stability, the surgeon should consider the size and shape of the fracture or augmentation area.Warnings: the devices can break or be damaged due to excessive activity or trauma.This could lead to failure of the implant construct, which could require additional surgery and device removal.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for synpor square sheet-sile 50x50/0.8 thick based on the investigation findings, the root cause is traced to design.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
Event or Problem Description
It was reported that before the surgery, synpor packaging was opened and it was noted that the device had a hole in it.Another device was used to complete the surgery.There were no adverse consequences to the patient.There was no surgical delay.

• Brand Name: SYNPOR SQUARE SHEET-SILE 50X50/0.8 THICK
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 21911743
• Report Number: 8030965-2025-04082
• Device Sequence Number: 21102622
• Product Code: FTL
• UDI-Device Identifier: 10887587026039
• UDI-Public: (01)10887587026039(17)20270201(10)DS7009059
• 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

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: DS7009059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown