MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 4.3MM DRILL BIT QC/221MM; BIT,DRILL

Catalog Number	310.430
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s date of birth/age and weight are not available for reporting.Device is an instrument and is not implanted/explanted.Complainant device is not expected to be returned for manufacturer review/investigation.Facility phone number is not provided for reporting.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested and is currently pending completion.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 reports an event in (b)(6) as follows: it was reported that during knee surgery on (b)(6) 2018, the surgeon was removing a non-synthes plate to replace it with a synthes plate 4.5mm ti broad locking compression plate (lcp).When surgeon was using the drill bit to make the holes for the screws, the drill bit broke inside the patient and a fragment was left inside the patient.The surgeon indicated that the drill bit broke because it hit a previously implanted screw.There was no surgical delay reported.Concomitant devices reported: non-synthes plate (part #: unknown, lot #: unknown, quantity: 1), 4.5mm ti broad lcp® plate (part #: 426.641, lot #: unknown, quantity: 1), screws (part #: unknown, lot #: unknown, quantity: unknown).This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.A device history record review was performed for the subject device: part no.: 310.430.Lot no.: 9653248.Manufacturing location: bettlach.Release to warehouse date: 02.Oct.2015.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The drill bits (power driven) design and clinical risk management (dcrm) document, was reviewed and found to adequately address the complaint condition.Udi.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: 4.3MM DRILL BIT QC/221MM
• Common Device Name: BIT,DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7338560
• Report Number: 8030965-2018-52065
• Device Sequence Number: 18854906
• Product Code: HTW
• UDI-Device Identifier: 10886982186621
• UDI-Public: (01)10886982186621(10)9653248
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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,Followup
• Report Date (Section B): 02/14/2018

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: 310.430
• Device Lot Number: 9653248
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 05/10/2018
• 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