MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM; BIT,DRILL

Catalog Number 03.010.100

Device Problem Failure to Cut (2587)

Patient Problem No Code Available (3191)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device is not distributed in the united states but is similar to device marketed in the usa.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2020, the patient underwent a surgery for humeral shaft spiral fracture with multi-lock humeral nailing system.During drilling for distal screw with a radiolucent drive, the surgeon had difficulty in drilling bone because the drill bit was dull.The surgery was delayed by less than 30 minutes.The patient outcome was unknown.Concomitant device reported: unknown radiolucent drive (part # unknown, lot # unknown, quantity # 1).This is report 01 of 01 of (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.H3, h4, h6: a review of the device history record.Device history lot part number: 03.010.100, synthes lot number: u310530, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 03.July 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device history batch null h3, h6: investigation summary investigation selection investigation site: cq zuchwil , selected flow: damaged ¿ worn/dull.Visual inspection: the received drill bit is worn at the tip and therefore dull as complained.No other damages are visible.Dimensional inspection: because of the damages at the tip, the complaint relevant dimensions cannot be checked to print specifications anymore.Drawing/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The review has shown that the correct material was used according to the drawing.Summary: the complaint condition is confirmed, since the drill bit is worn/dull.The visible damages are clearly caused post manufacturing and is not due to any manufacturing non-conformances.It is likely that a mechanical overloading situation during use has caused the visible damages.Blunt drill bits require more mechanical power during the application, therefore should 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 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: 3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM
• Type of Device: BIT,DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9682130
• MDR Text Key: 192426830
• Report Number: 8030965-2020-00943
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819775374
• UDI-Public: (01)07611819775374
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.100
• Device Lot Number: U310530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 02/07/2020
• Supplement Dates Manufacturer Received: 03/02/2020
• Supplement Dates FDA Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN RADIOLUCENT DRIVE