MAUDE Adverse Event Report: SYNTHES GMBH SYNPOR SQUARE SHEET-STERILE 50MMX50MM/0.8MM THICK; MESH, SURGICAL

Model Number	08.510.120S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
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.H10 additional narrative: d2b: additional device product codes: ftl, gwo.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h4, h6: part:08.510.120s.Lot:ds7007483.Manufacturing site: werk selzach.Supplier:dsm biomedical.Release to warehouse date:01 jun 2021.Expiration date: 01 may 2026.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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 square sheet-sile 50x50/0.8 thick was found to be delaminated across several sections of the sheet and there are small flakes at the surface of the table.One of the fragments appears to be broken across the mid section.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 for the synpor square sheet-sile 50x50/0.8 thick.Relevant actions have been taken to address the issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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
Device report from synthes reports an event in china as follows: it was reported that during a rhinoplasty surgery on (b)(6) 2023, during cutting, it was noted that the device was broken off.Another device was used to complete the surgery, and there were no adverse consequences to the patient.There was no delay to surgery.No fragments were retained in the patient.This report involves one synpor square sheet-sterile 50mmx50mm/0.8mm thick.This is report 1 of 1 for pc-(b)(4).
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.H10 additional narrative: h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
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.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 the synpor square sheet-sile 50x50/0.8 thick was found broken in four parts, and was found to be delaminated in some sections of the product, one of the fragments appears to be broken across the mid section.No other issues were found.A dimensional inspection 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 contribute to the complained device issue.Based on the investigation findings, the root cause is traced to design.The product issue has been addressed through depuy synthes quality system.As part of depuy synthes 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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SYNPOR SQUARE SHEET-STERILE 50MMX50MM/0.8MM THICK
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohackerweg 5; selzach 2425 ; SZ 2425
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16750371
• Report Number: 8030965-2023-04698
• Device Sequence Number: 11620194
• Product Code: FTM
• UDI-Device Identifier: 10887587026039
• UDI-Public: (01)10887587026039
• 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,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: 05/01/2026
• Device Model Number: 08.510.120S
• Device Catalogue Number: 08.510.120S
• Device Lot Number: DS7007483
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 04/24/2023; 06/12/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 05/09/2023; 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 49 KG