MAUDE Adverse Event Report: SYNTHES HAGENDORF 5.0MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM; BIT, DRILL

Catalog Number	03.010.102
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement was reported.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Hospital telephone: (b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review was completed.Manufacturing location: (b)(4).Manufacturing date: 23.February 2006.No 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.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 three (3) separate drill bits are worn and not as sharp as they should be.No patient involvement reported.This report is for one (1) 5.0mm three-fluted radiolucent drill bit.This is report 2 of 3 for (b)(4).
Additional Manufacturer Narrative
Product development investigation was completed.The investigation summary indicates that the: we have received the following two drill bits for investigation: part 03.010.102 / #lot 1429588 / drill bit ø 5.0 mm, calibrated,l145 mm (manufacture date jan.2011).The investigation will be merged, since the complaint for the parts are identical.The investigation of the complained drill bits shows that the tip and the cutting edges are rounded and worn.Because of the damages the complaint relevant dimensions cannot be checked to print specifications anymore.A review of the dhr for the provided lot numbers was researched and no abnormal findings were identified.Manufacturing and inspection records indicated no problems with the lots in question.The measurable dimensions are well documented and all within the valid specifications.It is likely that the products were an often and intensive used instruments and the complaint condition was caused by regular wear during its 6 & 11 years of lifespan.Check instruments for sound surfaces, and correct adjustment and function.Do not use severely damaged instruments, instruments with unrecognizable markings, corrosion, or blunt cutting surfaces.Based on these findings, we conclude that the cause of failures is not due to any manufacturing non-conformances.No indication for product related issue was found.Device 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.
Additional Manufacturer Narrative
The subject device has been received by the manufacturer and is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental report.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: 5.0MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6954497
• Report Number: 3003875359-2017-10515
• Device Sequence Number: 19019017
• Product Code: HTW
• UDI-Device Identifier: 07611819782426
• UDI-Public: (01)07611819782426(10)1429588
• 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,Followup
• Report Date (Section B): 09/28/2017

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: 03.010.102
• Device Lot Number: 1429588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 10/24/2017; 12/13/2017
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 11/16/2017; 12/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1