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	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in china as follows: it was reported that during the rhinoplasty surgery on (b)(6) 2023, while opening the packaging, it was noted the device was broken off.Another device was used to complete the surgery.There were no adverse consequences to the patient.No surgical delay.This is report 1 of 1 (b)(4).This report is for (1) synpor square sheet-sterile 50mmx50mm/0.8mm thick.
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.D2 additional codes: ftl, gwo.E1 reporter telephone: (b)(6).H3, h4, h6 investigation summary : 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 sheet 50*50 t0.8 was found to be delaminated across several sections of the sheet and there are small flakes at the surface of the table.Also the device was found broken, the broken fragments were returned.The packing was received in good condition.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.Drawing/specifications reviewed? yes, reviewed.Device history part:08.510.120s, lot:ds7007039, manufacturing site: werk selzach, supplier: (b)(4), release to warehouse date: 01 apr 2021 , expiration date: 01 mar 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, 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): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16991332
• Report Number: 8030965-2023-06559
• Device Sequence Number: 11626740
• 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

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: 03/01/2026
• Device Model Number: 08.510.120S
• Device Catalogue Number: 08.510.120S
• Device Lot Number: DS7007039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 48 KG