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

Model Number	08.510.220S
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in south korea 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.A 2 minute surgical delay was noted.This is report 1 of 1 for (b)(4).This is for (1) synpor smooth square sheet 50mmx50mm/0.8mm thick-sterile.
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.D2 additional codes: ftl, gwo e1: reporter is j&j sales consultant h3, h4, h6 investigation summary the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from attachment.Visual analysis of the photo revealed that the surface of synpor smooth square sheet 50x50/0.8 -s [08.510.220s/ds7009741], exhibits signs of delamination.No other problem was identified.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 smooth square sheet 50x50/0.8 -s [08.510.220s/ds7009741].Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history product#:08.510.220s lot #:ds7009741 release to warehouse date:01 jun 2022 manufacturing site: werk selzach suppliers: dsm biomedical expiration date:01 may 2027 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 SMOOTH SQUARE SHEET 50MMX50MM/0.8MM THICK-STERILE
• 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: 16991410
• Report Number: 8030965-2023-06561
• Device Sequence Number: 20579153
• Product Code: FTM
• UDI-Device Identifier: 10887587026114
• UDI-Public: (01)10887587026114
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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 Model Number: 08.510.220S
• Device Catalogue Number: 08.510.220S
• Device Lot Number: DS7009741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown