MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DRILL BIT Ø2 W/MARKING L110/85 2FLUTE; BIT, MILLING STERILE AND NON

Catalog Number 310.534

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/06/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is company representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 while drilling a surgical procedure on (b)(6) 2020, the tip of the drill bit broke off.The tip could not be removed, therefore, remains insitu.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.H11: b1, b2, b5, h1: the initial complaint was reviewed and found to be a duplicate of another complaint (b)(4).All information for this event will be captured on manufacturer report number 8030965-2020-02663.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 initial complaint was reviewed and found to be a duplicate of another complaint (b)(4).All information for this event will be captured on manufacturer report number 8030965-2020-02663.

• Brand Name: DRILL BIT Ø2 W/MARKING L110/85 2FLUTE
• Type of Device: BIT, MILLING STERILE AND NON
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9884723
• MDR Text Key: 193689804
• Report Number: 8030965-2020-02322
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 07611819158962
• UDI-Public: (01)07611819158962
• 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: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 310.534
• Device Lot Number: 9524036
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention