MAUDE Adverse Event Report: SYNTHES GMBH SYNPOR SQUARE SHEET-S 50X50/0.45 THICK; MESH, SURGICAL

Catalog Number	08.510.110S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
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.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1 initial reporter facility name: (b)(6).H6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 june 18, 2024, during the surgery, the device was found to have a hole.Another device was used to complete the surgery.There was no surgical delay.There were no adverse consequences to the patient.This report involves one (1) synpor square sheet-sterile 50mmx50mm/0.45mm thick.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes 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 reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission the , depuy synthes, ot its employees caused or contributed to the potential event described in this report.H3, h6, photo investigation: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that the synpor sheet synpor square sheet-s 50x50/0.45 thick, exhibits signs of delamination on the corners and in the lower right corner and missing material that appears to be a hole near of a corner could be observed.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 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 synpor square sheet-s 50x50/0.45 thick would contribute to the complained device issue.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# 08.510.110s, lot # ds7006481, manufacturing site: dsm biomedical, supplier: na , release to warehouse date: 01 mar 2021, expiration date: 01 jan 2026.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, follow-up medwatch will be filed as appropriate.

• Brand Name: SYNPOR SQUARE SHEET-S 50X50/0.45 THICK
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19749211
• Report Number: 8030965-2024-08750
• Device Sequence Number: 8987664
• Product Code: FTM
• UDI-Device Identifier: 10887587026015
• UDI-Public: (01)10887587026015(11)210301(17)260101(10)DS7006481
• 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 Expiration Date: 01/01/2026
• Device Catalogue Number: 08.510.110S
• Device Lot Number: DS7006481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown