MAUDE Adverse Event Report: SYNTHES GMBH CABLE CUTTER; CUTTER, WIRE

Catalog Number 03.607.513

Device Problem Break (1069)

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

Event Date 10/22/2021

Event Type  malfunction  

Manufacturer Narrative

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 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 procedure on (b)(6), 2021, the surgeon failed to follow instructions to use the front cutter and the instrument was damaged.A piece near the nose of the instrument chipped off.Device fragments were easily removed.Procedure was completed successfully with no delay.There was no patient consequence.This report is for a cable cutter.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Visual inspection: the front cutter (p/n: 03.607.513, lot number: 9924796) was received at us cq.Visual inspection of the complaint device showed the tip of the jaw had broken off.This is possibly due to being used to cut a k-wire, despite the device indicating not to use it with k-wires.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: dimensional inspection was performed for the design of device.No design issues or discrepancies were identified.Investigation conclusion: this complaint is confirmed as the tip of the jaw had broken off.No definitive root cause could be determined based on the provided information, however it is possible the device was used to try and cut k-wires, despite the device saying not to cut k-wires.There was no indication that a design or manufacturing issue contributed to the complaint.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 - no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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: CABLE CUTTER
• Type of Device: CUTTER, WIRE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SYNTHES UMKIRCH (DE); im kirchenhürstle 4-6; umkirch bei freiburg 79224 ; GM 79224
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12860892
• MDR Text Key: 281143760
• Report Number: 8030965-2021-09717
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 07611819880313
• UDI-Public: (01)07611819880313
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.607.513
• Device Lot Number: 9924796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 01/06/2022
• Supplement Dates FDA Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2016
• 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