MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC; BIT,DRILL

Catalog Number	03.010.228
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is an instrument and is not implanted / explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, during the procedure, the tip of the drill broke.Reportedly, at least the length of the tip (2 cm) remained in the head of the left femur.The surgeon tried to remove the piece of drill but he was unsuccessful.Patient outcome was reported as good.This report is for one (1) drill bit for 5.0mm recon screws/large qc.This is report 1 of 1 for (b)(4).

• Brand Name: DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC
• Common Device Name: BIT,DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7578886
• Report Number: 8030965-2018-54185
• Device Sequence Number: 11278313
• Product Code: HTW
• UDI-Device Identifier: 07611819307711
• UDI-Public: (01)07611819307711
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2018

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: 03.010.228
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/07/2018
• 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: 15 YR