MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; BIT, DRILL

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

Patient Problem Nerve Damage (1979)

Event Date 04/17/2018

Event Type  Injury  

Manufacturer Narrative

Patient date of birth and weight not available for reporting the 510k: this report is for an unknown drill bit/unknown lot.Part and lot numbers are unknown; udi number is unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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 japan as follows: it was reported patient underwent an open reduction internal fixation (orif) for proximal humeral fractures on (b)(6) 2018.The first screw insertion was completed on a proximal hole.Surgeon then drilled on either the proximal or distal side, but could not remember which side was actually drilled.Without removing the drill bit from the bone, surgeon inserted a multiloc screw.Another multiloc screw was then inserted on the other side.Surgery was completed with no delay.It was further reported that right after the procedure was completed, it was noticed that the patient had suffered from nerve paralysis on the left radius.Surgeon noted that drilling across the distal hole may have damaged the radius nerve, thus causing the neuroplegia.Patient is reported to be recovering slightly through rehabilitation with electrotherapy and other treatments.It is estimated recovery from the paralysis may take up to six (6) monthes.No further surgery is planned at this time.Concomitant devices reported: 4.5mm multiloc screw length 42mm (04.019.042s, lot l708336, quantity 1), 8mm multiloc proximal humeral nail-left-cannulated-160mm (04.016.035s, lot 5944386, quantity 1), 4.5mm multiloc screw length 40mm (04.019.040s, lot number unknown, quantity 1).This report is for one (1) unknown 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.Event date was corrected to (b)(6) 2018 since event occurred intra-operatively on that day.Device manufacturing site is unknown and was reported to be grenchen in (b)(4) in error.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.

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.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.

• Type of Device: BIT, DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7527639
• MDR Text Key: 108722834
• Report Number: 8030965-2018-53867
• Device Sequence Number: 1
• Product Code: HTW
• 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,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR