MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC SYNPOR SQUARE SHEET-STERILE 50MMX50MM/0.8MM THICK; MESH, SURGICAL

Catalog Number 08.510.120S

Device Problem Break (1069)

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

Event Date 10/20/2021

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, it was reported that during trimming prior to rhinoplasty surgery, the plate was broken.The material of the product lot was more brittle and thinner than ever used ones, which was different from the previous ones.The patient outcome was stable.This complaint involves (1) device.This report is for (1) synpor sheet 50*50 t0.8.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: ftl, gwo.Reporter is a j&j representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.H3, h6: part: 08.510.120s.Lot: ds7006560.Manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: 01 february 2021.Expiration date: 01 january 2026.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Note: following investigation was performed by the supplier.The product was returned to depuy synthes for evaluation.The depuy synthes team forwarded the device to the supplier which conducted a visual inspection of the returned device.Dsm reviewed all related device history records and associated risk documentation¿related to plate broken during trimming¿and no discrepancies were identified.The product was observed to have broken into many small pieces with irregular edges.The entire returned product was broken into small pieces, and therefore it was not possible for dsm to replicate the failure during the investigation.The team assessed the failure and identified an issue during sintering as the most likely source of the brittleness observed during use of the device.Dsc testing was conducted on samples from each of the returned products in addition to a device deemed representative of an acceptable product.Test results did not provide conclusive evidence to explain the failure of the items returned in this complaint.The dsc peak observed for the broken product was similar to the acceptable product.The source of this failure could not be reached to demonstrate that it is related to a dsm controlled operation.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 sheet 50*50 t0.8.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.

• Brand Name: SYNPOR SQUARE SHEET-STERILE 50MMX50MM/0.8MM THICK
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12856063
• MDR Text Key: 281165438
• Report Number: 8030965-2021-09701
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 07611819315853
• UDI-Public: (01)07611819315853
• 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,Followup
• Report Date: 10/27/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 08.510.120S
• Device Lot Number: DS7006560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 06/30/2022
• Supplement Dates FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1