MAUDE Adverse Event Report: SYNTHES GMBH SMALL WIRE CUTTER 160MM; CUTTER, WIRE

Catalog Number 391.90

Device Problem Material Deformation (2976)

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

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: part: 391.900, lot: t199243.Manufacturing site: (b)(4).Release to warehouse date: september 15, 2020 a review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the small wire cutter 160mm was returned and received at us customer quality (cq).Upon visual inspection, that there is a slight gap between the cutters jaws and therefore are not closing properly and the jaws are slightly deformed.No other issues were identified with the returned components of the device.Functional test was not performed but the alleged dull/will not cut can be confirmed since there is gap between jaws and they are deformed.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy because of the design of the device.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed: cable cutter pinch-large orthopaedic cable system.Investigation conclusion: the complaint condition is confirmed for the small wire cutter 160mm.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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that the wire cutters jaws are not closing properly and were not able to cut the wire.This occurred during testing, so no patient was involved.No further information is available.This report is for a small wire cutter 160mm.This is report 1 of 1 for (b)(4).

• Brand Name: SMALL WIRE CUTTER 160MM
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12031983
• MDR Text Key: 261742212
• Report Number: 8030965-2021-05110
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 07611819024762
• UDI-Public: (01)07611819024762
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 391.90
• Device Lot Number: T199243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1