MAUDE Adverse Event Report: SYNTHES GMBH SYNPOR TI REINFORCED FAN PLATE FIXTN HOLES/0.8MM THICK-STER; MESH, SURGICAL

Catalog Number 08.520.121S

Device Problems Defective Device (2588); Material Integrity Problem (2978)

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

Event Date 07/24/2023

Event Type  malfunction  

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.H10 additional narrative: e3: reporter is a j&j employee.H3, h6: a product investigation was conducted.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/titan orbit-fl-mesh-pl rad 43.6 w was found cut/broken at the tab location and flush with part edge the titanium.Both fragments were received.In addition, the polyethylene was intact and no damaged could be observed.A dimensional inspection was performed for the synpor/titan orbit-fl-mesh-pl rad 43.6 w and met specifications.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.The overall complaint was confirmed as the observed cut/broken condition of the synpor/titan orbit-fl-mesh-pl rad 43.6 w, would contribute to the complained device issue.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.H3, h4, h6: device history record (dhr) review conducted: part# 08.520.121s.Lot # ds7010424.Supplier: dsm biomedical.Manufacturing site: werk selzach logistik.Release to warehouse date: 01 oct 2022.Expiration date: 01 sep 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.

Event Description

Device report from depuy synthes reports an event in south korea as follows: it was reported that a polyethylene part of synpor is not consistent in thickness.There was a three (3) minutes of surgical delay due to the reported event.The surgery was completed successfully with the extra stock.There was no patient consequence.During manufacturer's investigation of the returned device it was identified that the synpor/titan orbit-fl-mesh-pl rad 43.6 w was found cut/broken at the tab location and flush with part edge the titanium.This report is for one (1) synpor ti reinforced fan plate fixtn holes/0.8mm thick-ster.This is report 1 of 1 for complaint #: (b)(4).

• Brand Name: SYNPOR TI REINFORCED FAN PLATE FIXTN HOLES/0.8MM THICK-STER
• Type of Device: MESH, SURGICAL
• 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 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18321753
• MDR Text Key: 330948209
• Report Number: 8030965-2023-15668
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 07611819315990
• UDI-Public: (01)07611819315990
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08.520.121S
• Device Lot Number: DS7010424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1