MAUDE Adverse Event Report: SYNTHES GMBH BOLT CUTTER HEAD FOR 5.0MM FIXATION PINS XL; CUTTER, WIRE

Catalog Number	391.771
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that during a procedure on (b)(6) 2021, while cutting the final transpedicular schanz screw, the metal fragments broke off the bolt cutting head.No reports of these fragments entering the operative site.Instrument was removed from the set.There was no surgical delay or patient impact.This report is for one (1) bolt cutter head for 5.0mm fixation pins xl.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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.

• Brand Name: BOLT CUTTER HEAD FOR 5.0MM FIXATION PINS XL
• Common Device Name: CUTTER, WIRE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11753664
• Report Number: 8030965-2021-03470
• Device Sequence Number: 17088420
• Product Code: HXZ
• UDI-Device Identifier: 07611819112216
• UDI-Public: (01)07611819112216
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 391.771
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRANSPEDSCHANZSCR Ø6.2 L180/35 TAN DBLUE