MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - DRILL BITS: TRAUMA

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

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 12/10/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - drill bit: trauma/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.(b)(4).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 an unknown date that the patient had removal surgery of aiming arm but after reattachment, the aiming arm would not attach securely to nail insertion handle and when drilled through, missed the hole in the nail.The surgeon had to remove the aiming arm entirely and drill bit entered bone at angle different to nail holes.The surgery was delayed 5 minutes.The procedure was completed successfully.The patient outcome was unknown.Concomitant device reported: unknown nail (par#: unknown, lot#: unknown, quantity#: 1); unknown drill sleeve (par#: unknown, lot#: unknown, quantity#: 1).This is report 3 of 3 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.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: UNK - DRILL BITS: TRAUMA
• Type of Device: DRILL BIT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9544857
• MDR Text Key: 189161861
• Report Number: 8030965-2020-00022
• 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
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2020
• Patient Sequence Number: 1
• Treatment: UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - NAILS
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR