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

Catalog Number	08.510.120S
Medical Device Problem Codes	Material Discolored (1170); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery, upon opening the packing, it was noted that the device was broken off and had yellowing discoloration.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Investigation summary the product was not returned to j&j medtech orthopedics.However, a video was provided for review.The video investigation revealed the sheet is observed separated non-symmetrically, indicating sheet might have broken.Additionally, a foreign yellow substance is noticed along on of the sides of the sheet.The reported condition can be confirmed.However, the condition of the device upon newly receipt and before packaging was opened remains unknown.Therefore, the complete potential cause cannot be established.Properly handling and attention to the approved use of the device diminishes the risk of failure.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.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, the potential cause can not be established, and 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 orthopedics 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.Device history lot: part: 08.510.120s.Lot: ds7009555.Manufacturing site: werk selzach.Release to warehouse date: 01.July.2022.Expiration date: 01.June.2027.Supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Dhr review retrieved from (b)(4) as the impacted products share the same lot number.
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.H11 additional narrative: added: d9.Corrected: e4.Recaptured codes on h6 (medical device problem code).H3, h4, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device revealed that the synpor sheet 50*50 t0.8 was found cut into three fragments with a yellowish coloration on all surface.It is unknow if the missing cut portion of the implant also exhibited the yellowish coloration, as it was not returned for analysis.Additionally, its appears that the product was handled and intentionally cut into two portions measuring approximately 2.5mm x 3.5mm.This condition does not seem to reflect the original state of the product prior to opening the package.However, the reported condition can be partially confirmed.The complete potential cause cannot be established.Properly handling and attention to the approved use of the device diminishes the risk of failure.A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional evaluation was not performed as it is 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.Device history review (dhr): part : 08.510.120s.Lot : ds7009555.Manufacturing site: werk selzach.Release to warehouse date: 01.July.2022 expiration date: 01.June.2027.Supplier: (b)(4).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.

• 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: 23347529
• Report Number: 8030965-2025-10549
• Device Sequence Number: 18158610
• Product Code: FTL
• UDI-Device Identifier: 10887587026039
• UDI-Public: (01)10887587026039(17)270601(10)DS7009555
• 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,Followup

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: DS7009555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown