MAUDE Adverse Event Report: SYNTHES TUTTLINGEN 40 DEG UP-BITING LAMINECTOMY PUNCH 4MM WIDTH/254MM LENGTH; MISC ORTHO SURGICAL INSTR

Catalog Number	03.605.520
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Patient Involvement (2645)
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).The investigation could not be completed; no conclusion could be drawn, as no product was received.Review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications, confirm that the components and final product met inspection records.All (b)(4) parts of the lot were checked 100% for important features and for function at the final inspection on 18-may-2010.No ncrs were generated during production.Manufacture location: synthes (b)(4).Manufacture date: may 27, 2010.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 is reported that during cleaning it was noted the up-biting laminectomy punch is not functioning properly.Closer inspection noted the inner part that pushes bone out of the instrument was broken.The broken piece has been discarded.No patient or surgery involvement.This report is for one (1) up-biting laminectomy punch.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.A manufacturing investigation was performed for the subject device (40 deg up-biting laminectomy punch 4mm width/254mm length, part number 03.605.520, lot number t946700).The subject device was returned to the manufacturer with the complaint condition stating: the punch is showing some post release wear around the cutting edges which would be typical for device of this age (approx.7 years).The device is functioning quite well; however, there are some squeaking noises when squeezing the handles.The design does not include an inner part that pushes bone out of the instrument.The present design is the same.A function test of the handles show that they are functioning properly but are squeaking, which only would require a little oiling.Therefore, the manufacturing evaluation shows that there were no issues during the manufacture of the product that would contribute to this complaint condition.No further inspections can would be relevant to the complaint condition.No manufacturing issue was found during investigation; therefore, no prm documents were reviewed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 40 DEG UP-BITING LAMINECTOMY PUNCH 4MM WIDTH/254MM LENGTH
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6447982
• Report Number: 9680938-2017-10059
• Device Sequence Number: 10904421
• Product Code: LXH
• UDI-Device Identifier: 07611819317703
• UDI-Public: (01)07611819317703(10)T946700
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2017

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: 03.605.520
• Device Lot Number: T946700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2017
• Supplement Report FDA Received Date: 04/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1