MAUDE Adverse Event Report: SYNTHES GMBH WIRE CUTTER 220MM; CUTTER, WIRE

Catalog Number 391.93

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.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 medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that during an unknown procedure on an unknown date it was identified that there is a missing corner where the front end cuts the wire.Surgeon used a new one with no other issues.No patient consequences reported.This report is for one (1) wire cutter 220mm.This is report 1 of 1 for complaint (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.Investigation summary the narrative could not be confirmed based on the received picture.It is only the packaging and labeling visible.Product was not returned.Based on the information available, it has been determined that no corrective and 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 part number: 391.93, lot number: t187053, manufacturing site: tuttlingen, release to warehouse date: jan 23, 2020.A review of the device history records was performed for the finished device lot number, 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.Purpose: the reason for this rational is the complaint (b)(4).It was objected that there are chamfers on the front cutting edges of each of the stellite inserts.Summary: the chamfer is protecting the tip of the cutting edge to avoid breakage due to shear force.If the corner would be sharp the shear stress would be higher, and the brittle material can break.The two chamfers on the cutting plates at the front do not affect the cutting performance in any way but increase the wear resistance of the article.It is hereby clarified that all items 391.930 which were manufactured by jabil tuttlingen (formerly synthes tuttlingen) were always manufactured with these chamfers as shown.They were never manufactured otherwise.To eliminate these ambiguities in the future, jabil tuttlingen is requesting a drawing amendment to include and specify these chamfers.As investigations performed didn¿t identify any manufacturing defect or deficiency, therefore the in the investigation flow listed remaining investigation steps are not required.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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: WIRE CUTTER 220MM
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10861324
• MDR Text Key: 217673268
• Report Number: 8030965-2020-09014
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 07611819024779
• UDI-Public: (01)07611819024779
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391.93
• Device Lot Number: T187053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2020
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1