MAUDE Adverse Event Report: SYNTHES BETTLACH 2.8MM DRILL BIT/QC/165MM; BIT, DRILL

Catalog Number	310.288
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	12/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight is not available for reporting.Device is an instrument and is not implanted / explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device history records review was completed for part# 310.288, lot# 2513400.Manufacturing location: (b)(4), manufacturing date: jul 29, 2009.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
It was reported that the patient underwent surgery on (b)(6) 2016 to treat a proximal humerus fracture.During the procedure while the surgeon was drilling for screw placement the 2.8 mm drill bit broke off in the patient.The fragment piece was not retrieved because the surgeon felt that it would cause further bone destruction.An x-ray taken at the time showed the fragment finding.Another drill bit was available for the surgeon to successfully complete the procedure.There was no surgical delay.The patient outcome was stable.Concomitant devices reported: screw (quantity 1).This report is for one (1) drill bit.This is report 1 of 1 for (b)(4).

• Brand Name: 2.8MM DRILL BIT/QC/165MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 6219400
• Report Number: 9612488-2017-10004
• Device Sequence Number: 717486
• Product Code: HTW
• UDI-Device Identifier: 10886982186423
• UDI-Public: (01)10886982186423(10)2513400
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2016

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: Physician
• Device Catalogue Number: 310.288
• Device Lot Number: 2513400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2016
• Initial Report FDA Received Date: 01/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ONE (1) UNKNOWN SCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR