MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.8MM 3-FLUTED DRILL BIT QC/200MM; BIT,DRILL

Catalog Number	03.120.041
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is not available for reporting.Not implanted or explanted, partial device remained in patient.Complainant part is not expected to be returned for manufacturer review/investigation, as part remains in the patient.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.
Event or Problem Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that during an unknown orthopedic procedure on (b)(6) 2018.The three-fluted drill bit was split and remained inside the patient's bone.This happened while surgeon was perforating the bone to use a periprosthetic plate.The surgeon decided to leave the tip of the drill bit in the patient's bone to avoid damaging the tissue.It is unknown if there was a surgical delay.Patient and surgical outcome were both unknown.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
Additional 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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
Concomitant device: plate (part: unknown, lot: unknown, quantity: 1).

• Brand Name: 2.8MM 3-FLUTED DRILL BIT QC/200MM
• Common Device Name: BIT,DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7939446
• Report Number: 8030965-2018-57024
• Device Sequence Number: 14029679
• Product Code: HTW
• UDI-Device Identifier: 07611819996311
• UDI-Public: (01)07611819996311
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup
• Report Date (Section B): 09/16/2018

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: 03.120.041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/16/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 10/29/2018
• 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