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 Consequences Or Impact To Patient (2199)

Event Date 02/04/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 the patient underwent an osteosynthesis surgery for humeral diaphyseal fracture.The surgeon used a gimlet before drilling,during the insertion of distal locking screws the devices stopped.There was no problem when the surgeon drilled the cortical bone but the radiolucent drive and drill bits stopped gradually and it finally stopped with a ticking sound.The surgeon inserted the first locking screw without the radiolucent drive.Before the insertion of the second locking screw, the surgeon replaced the buttery and the drill bit which had heated, and he cooled the adapter and the connecting part of the radiolucent drive with saline.During the insertion of the second screw, the radiolucent drive stopped the same way as the first insertion and the surgeon inserted the screw without it.The surgeon did not apply the force excessively to the devices.The surgery was delayed 30 minutes and the patient was stable.Concomitant medical products: unknown radiolucent drive (part# unknown, lot# unknown, quantity# 1).Unknown battery (part# unknown, lot# unknown, quantity# 1).Unknown screws (part# unknown, lot# unknown, quantity# unknown).This report is for one 3.2mm three-fluted radiolucent drill bit/needle point/145mm.This is report 2 of 3 for (b)(4).This report is linked to (b)(4).

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.H3, h6: part: 03.010.100, lot: u334142, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 05.March 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the visual inspection of the returned drill bit has shown that the cutting edges are completely worn out damaged.The instrument is all in all in used condition and there are clearly wear marks and scratches on the tip section visible.Functional test: based on the visible damages at the returned device a functional test cannot be performed anymore.Dimensional inspection: measurement outer diameter = "pass" document/specification review: the certificate of the raw material was reviewed during the performed device history review and meet specification.The material was reviewed and the hardness value was confirmed to meet the specification with no non-conformance noted.Summary: the received condition of the drill bit is concordant with the complaint description and the complaint condition is confirmed.This lot was manufactured in march 2019 according to the specification.There were no issues during the manufacture of this product that would contribute to this complaint condition.The damage occurred is determined to be post production criteria¿s.Since the drill bit is in very used condition and the cutting edges are blunt, we would like to draw your attention on page 4 in the leaflet ¿important information¿: 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 manufacturing investigation results we conclude that the cause of failure is not due to any manufacturing non-conformances.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: 9749797
• MDR Text Key: 188245091
• Report Number: 8030965-2020-01360
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819775374
• UDI-Public: (01)07611819775374
• Combination Product (y/n): N
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• 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: U334142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - POWERED DRIVERS/HANDPIECES; UNK - POWERED DRIVERS/HANDPIECES: BATTERY; UNK - SCREWS: TRAUMA
• Patient Age: 47 YR