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); Material Fragmentation (1261)

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

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary: 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 an event in (b)(6) clinic, the doctor asks for a drill to perform hole opening in the femur because he needed to perform a universal nail screw extraction which did not come out and needed to open a space for the extraction, the tip of the part bit remained within the patient without any affectation to it.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity unknown).Unknown nail (part# unknown, lot# unknown, quantity 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

Event Description

Concomitant devices: powered drivers/handpieces (part: unknown, lot: unknown, quantity: 1).

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.E3: reporter is a synthes employee.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: 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: 9578318
• MDR Text Key: 189184142
• Report Number: 8030965-2020-00266
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 02/04/2020
• Patient Sequence Number: 1
• Treatment: UNK - NAILS; UNK - POWERED DRIVERS/HANDPIECES; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention