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

Catalog Number	03.614.021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2021, the surgeon went to cut a rod and noted that the rod cutter was damaged and difficult to use.A second rod cutter was used.Procedure was completed successfully with no delay.There was no patient consequence.Upon manufacturer investigation, it was determined that the device had deformed cutting surfaces.Additionally, two of the welds holding the screws in place were observed to be broken.The device was difficult to open and close, likely due to the screws becoming misaligned after the welds broke.This report is for a rod cutter.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Part: 03.614.021, lot: t941956, manufacturing site: (b)(4), release to warehouse date: november 24, 2009.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that cutting-pliers f/r had deformed cutting surfaces.Two of the welds holding the screws in place were observed to be broken.The device was difficult to open and close, likely due to the screws becoming misaligned after the welds broke.No other defects were noted.A dimensional inspection was unable to be performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the cutting-pliers f/r would contribute to the complained device issue.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.Drawing/specifications reviewed.Current and manufactured revisions were reviewed.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: ROD CUTTER
• Common Device Name: 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14278269
• Report Number: 8030965-2022-02890
• Device Sequence Number: 6173337
• Product Code: HXZ
• UDI-Device Identifier: 07611819968424
• UDI-Public: (01)07611819968424
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.614.021
• Device Lot Number: T941956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - RODS.
• Patient Age: 67 YR
• Patient Sex: Male