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

Catalog Number 08.510.120S

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

Additional procodes: ftl, gwo.Complainant part is not expected to be returned for manufacturer review/investigation.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.(b)(4).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 (b)(6) reports an event as follows: it was reported that during a blowout fracture repair on (b)(6) 2020, the synpor sheet was damaged during the cutting process.The sheet cracked easily.The surgeon used a non-synthes product instead.The procedure was completed with no delay.Patient status was normal.This report is for a synpor square sheet.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.Depuy synthes summary: product was not returned.Reviewing attached picture, we can only confirm that one piece of the product is missing.The cause of the event "damaged during the simple cutting process" cannot be confirmed by the received pictures.Hence, this the complaint will be rated as n/a.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 history lot : dhr review was performed by supplier dsm biomedical as part of the investigation.Device history batch : null.Device history review : null.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): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10704026
• MDR Text Key: 212317734
• Report Number: 8030965-2020-08056
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 07611819315853
• UDI-Public: (01)07611819315853
• Combination Product (y/n): N
• PMA/PMN Number: K051879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08.510.120S
• Device Lot Number: DS7000796
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2020
• Patient Sequence Number: 1
• Treatment: UNK - SCISSORS
• Patient Outcome(s): Required Intervention