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

Catalog Number	03.037.027
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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 or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that during a trochanteric fixation nail advance (tfna) procedure on (b)(6) 2018, the tap for tfna screw broke off in the patient.During the procedure, the surgeon struggled to drill into the femur neck, then took the tap and started tapping.The tap broke off in the patient and the broken fragment was left in the patient.The surgeon closed the patient with plans to revise at a later date.It was unknown if there was a surgical delay.Concomitant device: drill (part: unknown, lot: unknown, quantity: 1).This report is for a tap for screw.This is report 1 of 1 for (b)(4).

• Brand Name: TAP FOR SCREW
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8134852
• Report Number: 8030965-2018-58770
• Device Sequence Number: 11328283
• Product Code: HTW
• UDI-Device Identifier: 07611819642539
• UDI-Public: (01)07611819642539
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.037.027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR