MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.8MM DRILL BIT/QC/165MM; BIT,DRILL

Catalog Number	310.288
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, during a wrist fusion procedure, the drill bit became blunt during the first screw insertion.The surgeon used another drill bit from the set to complete the procedure.There was no surgical delay.No patient consequence was reported.Concomitant device reported: unknown screw (part #: unknown, lot #: unknown, quantity: 1).This report is for one (1) 2.8mm drill bit/qc/165mm.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Part 310.288, lot 9377162: manufacturing site: bettlach.Release to warehouse date: february 20, 2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A product investigation was completed: the visual inspection with a 10x magnifier has shown that the cutting edges at the forefront of the drill bit are damaged.Otherwise the drill bit is in a good condition with no visible damage.The cutting edges are damaged and therefore not sharp anymore.The complained malfunction can be confirmed without a function test due to the damage.The dimensional inspection showed the features were conforming.The relevant dimensions at the cutting edges cannot be verified anymore due to the damage.The relevant drawings were reviewed.The complaint is confirmed as the cutting edges of the received drill bit are damaged, which has a direct influence on the cutting function of the device.This lot of devices were manufactured in february 2015 no manufacturing related issue could be detected.Based on the provided information the exact cause of this occurrence cannot be defined, it can only be assumed that an excessive metallic contact did cause the damage of the cutting edges.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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: 2.8MM DRILL BIT/QC/165MM
• Common Device Name: BIT,DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8544079
• Report Number: 8030965-2019-63114
• Device Sequence Number: 13889286
• Product Code: HTW
• UDI-Device Identifier: 07611819796904
• UDI-Public: (01)07611819796904
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 03/29/2019

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: 310.288
• Device Lot Number: 9377162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1