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

Model Number 08.510.120S

Device Problems Break (1069); Defective Device (2588)

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

Event Date 10/12/2022

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.Additional device product codes: ftl, gwo.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial , a follow-up will be filed as appropriate.

Event Description

Device report from synthes reports an event in china as follows: it was reported that before the surgery on (b)(6) 2022, the surgeon opened the unused packing and noted the material of the product was softer than products used before, and the plate broke after slight bending.Another device was used to complete the surgery.There were no adverse consequences to the patient, and there was no delay caused by this event.No further information is available.This report involves one synpor square sheet-sterile 50mmx50mm/0.8mm thick.This is report 1 of 1 for (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.H3, h4, h6: 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 dsm which conducted a visual inspection of the returned device.The returned device was investigated for issues related to the described complaint condition.The returned product was examined, and there was no breakage or defect on the parts.The complaint condition could not be confirmed from the returned device.All related device history records and risk assessments were reviewed, and no discrepancies applicable to this complaint were noted.Manufacturing controls are in place to ensure product meet all defined specifications.100% thickness check is completed during manufacturing process.No further action will be taken at this time.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for the synpor square sheet-sile 50x50/0.8 thick (08.510.120s/ds7006903).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 history lot part: 08.510.120s, lot: ds7006903, release to warehouse date: 01.Mar.2021, expiration date : 01.Feb.2026, supplier: (b)(4), manufacturing site: werk selzach.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.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part: 08.510.120s, lot: ds7006903, release to warehouse date: 01.Mar.2021, expiration date : 01.Feb.2026, supplier: (b)(4), manufacturing site: werk selzach.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from the attachment.Visual analysis of the photo revealed that the synpor square sheet-sile 50x50/0.8 thick had broken since only one rectangular fragment is visible.Burr condition cannot be confirmed as there are no signs of this issue.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 the synpor square sheet-sile 50x50/0.8 thick.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.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-STERILE 50MMX50MM/0.8MM THICK
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohackerweg 5; selzach 2425 ; SZ 2425
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15724536
• MDR Text Key: 307611385
• Report Number: 8030965-2022-09274
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 10887587026039
• UDI-Public: 10887587026039
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 08.510.120S
• Device Catalogue Number: 08.510.120S
• Device Lot Number: DS7006903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1