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

Catalog Number	388.750
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: device was used for treatment, not diagnosis.Patient age/date of birth, and weight not reported.Device is an instrument and is not implanted/explanted.Device is not expected to return for investigation.(b)(6).A review of the device history records has been completed.Manufacturing location: (b)(4), manufacturing date: october 27, 2011.No non-conformance (ncrs) 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 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 a rod cutter broke intraoperatively on (b)(6) 2016 during an unknown procedure.All fragments were removed and none remained behind in the patient.There was no prolongation of surgery and the patient outcome was stable.This is report 1 of 1 for (b)(4).

• Brand Name: TABLE TOP ROD CUTTER AND BENDER
• Common Device Name: CUTTER
• Manufacturer (Section D): UMKIRCH; im kirchenhurstle 4; umkirch b. freiburg D-792 24; GM D-79224
• MDR Report Key: 6167090
• Report Number: 3003862213-2016-10040
• Device Sequence Number: 10890025
• Product Code: FZT
• UDI-Device Identifier: 07611819053243
• UDI-Public: (01)07611819053243(10)7648011
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2016

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: 7648011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2016
• Initial Report FDA Received Date: 12/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1