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

Catalog Number	391.771
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: device is an instrument and is not implanted/explanted.The subject device has been received and is currently undergoing investigation.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture: feb 28, 2002.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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
It was reported that during a t11-l1 posterior spinal fusion procedure, while the surgeon was cutting the schanz pins and after all of the hardware had been implanted, the head of a synthes bolt cutter head broke at the tip of the device.The surgeon retrieved all of the fragments easily with a delay of approximately one minute.A second device was available and the surgeon completed the procedure successfully.No adverse events were reported against the patient.Concomitant devices reported: unknown schanz pin (part #: unknown, lot #: unknown, qty.1).This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product development investigation was completed.A visual inspection, functional test and device history review were performed as part of this investigation.The complaint condition was confirmed as the instrument was returned with a portion of the distal tip of the sleeve being fractured off from the rest of the instrument.The balance of the device is in fair condition with signs of wear.Replication of the complaint condition is not applicable as its already broken.The bolt cutter head for 5.0 mm schanz screws is a component of the uss fracture system instrument and titanium implant set.The uss system is utilized for internal fixation for vertebral fractures in the thoracolumbar spine.The bolt cutter is specifically utilized to cut the shafts of the schanz screws off after final tightening of the assembly as per the technique guide.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Top level assembly was reviewed.No drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A definitive root cause was unable to be determined however a possible root cause could be rough handling and/or off axis loading.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 HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6455543
• Report Number: 3003875359-2017-10169
• Device Sequence Number: 591727
• Product Code: FZT
• UDI-Device Identifier: 10705034777269
• UDI-Public: (01)10705034777269(10)1117708
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2017

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
• Device Lot Number: 1117708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2017
• Supplement Report FDA Received Date: 05/02/2017
• 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: UNKNOWN SCHANZ PIN, QUANTITY 1