MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.2MM THREE-FLUTED DRILL BIT QC/330MM/100MM CALIBRATION; BIT,DRILL

Catalog Number 03.010.060

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Paralysis (1997); No Code Available (3191)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

A review of the device history records has been requested.Based on the received pictures, the reported complaint condition cannot be confirmed.(b)(4).The device has been 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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, an open reduction surgery was performed for the humeral surgical neck fracture 2-part fracture with multiloc humeral nail system.Upon drilling for the g locking screw, a reflex response was observed in the elbow when the drill penetrated the contralateral bone.The surgeon noticed the response and proceeded with the insertion of the locking screw 28mm carefully.After surgery when the patient awoke from anesthesia, they found the carpoptosis.It was then confirmed by the surgeon that the drill bit glanced the nerve during drilling on the first surgery.The first surgery and the re-operation happened on (b)(6) 2018.There was no surgical delay reported.The procedure outcome was unknown.This report addresses the intra-op event with the drill.Re-operation has been captured under linked complaint (b)(4).Concomitant device reported: distal locking screw (part # unknown, lot # unknown, quantity 1); drill ( part # unknown, lot # unknown, quantity 1); humeral nail ( part # unknown, lot # unknown, quantity 1).This report is for one (1) 3.2mm three-fluted drill bit.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.Visual inspection: the received drill bits shows signs of use such as mechanical damages on entire part's surfaces.Furthermore both tips and the respective cutting edges are rounded and worn.No product issues or defects could be identified.Summary: our investigation has shown that the received devices have signs of use on their surfaces.Based on the reported clinical information it was confirmed, that during first surgery the drill bit glanced the nerve.With that evidence we consider that the reported complaint condition is most likely referable to a user error.This investigation will be rated as unconfirmed, because no product related issue was identified.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 history lot part: 03.010.060, lot: 9763977, manufacturing site: bettlach, release to warehouse date: 13.Jan.2016.The device history record shows this lot 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.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 DRILL BIT QC/330MM/100MM CALIBRATION
• Type of Device: BIT,DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8232348
• MDR Text Key: 132564699
• Report Number: 8030965-2019-59681
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819760882
• UDI-Public: (01)07611819760882
• 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: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.060
• Device Lot Number: 9763977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Date Manufacturer Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention