MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM; BIT,DRILL

Catalog Number 03.010.104

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 12/24/2019

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Occupation: reporter is synthes sales consultant.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.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 synthes reports an event in (b)(6) as follows: it was reported that during an unknown procedure on (b)(6) 2019, surgeon used the expert tibial nailing set.During the procedure the 4.2 drill bit broke.Surgeon was unable to remove the broken bit.No further information provided.Concomitant device reported: expert tibial nail ( part#: unknown, lot#: unknown, quantity: 1).This report is for one (1) 4.2mm three-fluted drill bit qc/needle point/145mm.This is report 1 of 1 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.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

The patient required an open reduction internal fixation (orif) of a tibial fracture.The same size drill bit was used from the set to complete the surgery.The surgery was completed successfully.

• Brand Name: 4.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM
• Type of Device: BIT,DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9588529
• MDR Text Key: 189197522
• Report Number: 8030965-2020-00367
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 07611819775404
• UDI-Public: (01)07611819775404
• 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: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.104
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - NAILS: EXPERT TIBIAL
• Patient Outcome(s): Required Intervention