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

Catalog Number	391.906
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: reporter is a synthes employee.Part number: 391.906.Lot number: t940705.Manufacturing site: (b)(4).Release to warehouse date: (b)(6) 2009.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the cable cutter lrg was received at us customer quality (cq).Visual inspection of the complaint device showed the distal tip of the cutter had broken off, and one of the screws had come loose due to the stake breaking.Device failure/defect identified? yes dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/ specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the distal tip of the cutter had broken off, and one of the screws had come loose due to the stake breaking.No definitive root cause could be determined based on the provided information.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 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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, during an inspection, the cable tensioner was discovered as defective.No specific issue was identified.No surgical impact.No patient involvement.This report is for one (1) cable cutter-large.This is report 2 of 2 for (b)(4).

• Brand Name: CABLE CUTTER-LARGE
• 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 ; SZ 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13483079
• Report Number: 8030965-2022-00758
• Device Sequence Number: 5363311
• Product Code: HXZ
• UDI-Device Identifier: 07611819719880
• UDI-Public: (01)07611819719880
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Other
• 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: 391.906
• Device Lot Number: T940705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2009
• 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: CABLE TENSIONER.
• Patient Sex: Unknown