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

Model Number	08.510.220S
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
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.Additional procodes: ftm, gwo.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 china reports an event as follows: it was reported that on (b)(6) 2021, during comprehensive nasal surgery, the product in question was found with material defects.Upon opening the packing, delamination of the rough and smooth surfaces was noted by the specialist, and some particles came off the component.Another device was used to complete the procedure.There were no reported adverse patient consequences.No further information is available.This report is for a synpor smooth square sheet 50mmx50mm/0.8mm thick-sterile.This is report 1 of 1 for (b)(4).

• Brand Name: SYNPOR SMOOTH SQUARE SHEET 50MMX50MM/0.8MM THICK-STERILE
• 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: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 15147824
• Report Number: 8030965-2022-05490
• Device Sequence Number: 20270709
• Product Code: FTL
• UDI-Device Identifier: 10887587026114
• UDI-Public: (01)10887587026114
• 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: Physician
• 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: 03/01/2025
• Device Model Number: 08.510.220S
• Device Catalogue Number: 08.510.220S
• Device Lot Number: DS7005030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown