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 Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

Patient identifier, age, date of birth, and weight not available for reporting.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.Initial reporter address and telephone not available for reporting.Initial reporter is synthes affiliate.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: it was reported patient underwent an open reduction internal fixation (orif) procedure utilizing the multiloc humeral nail for humeral diaphyseal fractures on (b)(6) 2018.During the procedure while creating a hole for the distal locking screw, difficulty drilling the bone was noted.Surgery was completed with a delay of approximately 30 minutes.No adverse consequence to the patient was reported.Surgeon stated the issue was due to the radiolucent drive and the drill bit.(b)(4) addresses the issue with the radiolucent drive.This report addresses the drill bit.This report is for one (1) 3.2mm three-fluted radiolucent drill bit.This is report 1 of 1 for (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.Date device received by manufacturer.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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

This is report 1 of 2 for complaint: (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.A device history record (dhr) review was conducted.Part: 03.010.100 , lot: u306493 , manufacturing site: selzach , supplier: orchid bridgeport , release to warehouse date: 19.Mar.2018.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.A product investigation was conducted.Visual inspection shows that the tip of the drill bit is bent as result of misuse.Also, the cutting edges are damaged what caused the inefficient cutting performance while use.A repair of the device in question is not possible.The condition of the received drill bit agrees with the complaint description.In this condition, the drill bit is no longer usable.However even misuse was identified, this complaint is confirmed.No further (dimensional) investigations are required as device use could be identified as source of the reported problem.This drill bit was distributed from manufacturing without damages.No product fault could be identified.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: 7877212
• MDR Text Key: 120386773
• Report Number: 8030965-2018-56348
• 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,Followup
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2018
• 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: U306493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Date Manufacturer Received: 09/26/2018
• Patient Sequence Number: 1