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

Catalog Number 08.510.120S

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/26/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in china as follows: it was reported on (b)(6)2023, that during the surgery, opened the packing, noted the edges were rough and there was a hole in the device (as the photo shows).Another device was used to complete the surgery.There was no surgical delay.There were no adverse consequences to the patient.No additional information could be provided.This report is for one (1) synpor square sheet-sile 50x50/0.8 thick this is report 1 of 1 for complaint (b)(4).

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.D2b: additional product code: ftm,gwo.E3: reporter is a j&j employee.H3, h4, h6 the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the photo revealed that synpor sheet 50*50 t0.8 appears to be missing material at the center.Additionally, the device was found to be delaminated across several sections of the sheet.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 synpor sheet 50*50 t0.8.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.Part # 08.510.120s.Lot # ds7007140.Manufacturing site: werk selzach logistik.Release to warehouse date : 01.May.2021.Expiration date: 01.April.2026.Supplier: (b)(4).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.

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.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 synpor square sheet-sile 50x50/0.8 thick has missing material at the center of the sheet that could be interpreted as a hole.In addition, delaminated across several sections of the sheet also was observed.A dimensional inspection for the synpor square sheet-sile 50x50/0.8 thick was not performed as it is not applicable to reported condition.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-sile 50x50/0.8 thick would contribute to the complained device issue.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.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-SILE 50X50/0.8 THICK
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SELZACH LOGISTIK; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18642059
• MDR Text Key: 334882808
• Report Number: 8030965-2024-01963
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K051879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08.510.120S
• Device Lot Number: DS7007140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1