MAUDE Adverse Event Report: UMKIRCH TABLE TOP ROD CUTTER AND BENDER; CUTTER SURGICAL

Catalog Number	388.750
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Part 388.750, lot 7520783: manufacturing location: (b)(4).Manufacturing date: june 30, 2011.No non-conformance reports 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: it was reported that the device was used in surgery for the thoracolumbar kyphosis on (b)(6) 2016.After the surgeon inserted total of twenty-five (25) screws, he selected cocr rods instead of ti rods.Because the counter handle was not available, the surgeon connected only the cutting handle with the rod cutter.First he cut the depuy rod to be approximately 350 mm.The nurse put her weight to the rod cutter unit and finished by using the counter.Next, the surgeon tried to cut the second rod.When the rod was cut, the screw on the cutting handle broke.The chipped piece remained in the main part of the device.The surgery was completed without delay.There was no adverse consequence to the patient.Concomitant devices: rod (quantity 1).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: device returned to manufacturer.A product investigation was performed.One uss rod cutting and bending device was returned for investigation.The visual inspection of the uss rod cutting and bending device shows that the operating lever w/handle (component part 50134617 / 50134905) is broken and the threaded, broken-off part is stuck in the counter part 50136305.The review of the device history records revealed that this instrument was manufactured in june 2011 according to the specifications.The part conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.The operating lever w/handle is made from stainless steel (hardened and tempered); the hardness was measured at the time of the manufacturing and was found to be good.The broken surface is homogenous what indicates material conformity as well.Unfortunately the exact cause of failure cannot be determined; however, the failure mode is consistent with a mechanical overloading.No product related issues were found.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: TABLE TOP ROD CUTTER AND BENDER
• Common Device Name: CUTTER SURGICAL
• Manufacturer (Section D): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-792 24; GM D-79224
• MDR Report Key: 6246091
• Report Number: 3003862213-2017-10000
• Device Sequence Number: 18913030
• Product Code: FZT
• UDI-Device Identifier: 07611819053243
• UDI-Public: (01)07611819053243(10)7520783
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2016

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: 388.750
• Device Lot Number: 7520783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2017
• Supplement Report FDA Received Date: 02/02/2017
• 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: ONE (1) UNKNOWN ROD