MAUDE Adverse Event Report: SYNTHES ELMIRA 2.0MM DRILL BIT/QC/100MM; INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH

Lot Number	4830748
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information not available for reporting.Additional product codes: gff, gfa, hsz.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history record revealed no complaint related anomalies.The device history record shows lot 4830748 of 2.0 mm drill bits was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record(s) determined that the raw material lot 4540861 was issued one mrr: (b)(4).The synthes specification called out one specification (astm f 139), but the material was certified and re-certified under a different specification (astm f 138).The material was released as ¿use as is¿ with a rationale from pd stating that the raw material drawing would be revised to allow the use of the astm f 138 specification.Since the specification that the material was certified and re-certified under is acceptable, the material was properly certified, and there is no relevance to the complaint condition.Date of manufacture: 19 october 2004.Manufacturing location: (b)(4).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
Customer quality unit received a maude report forwarded from department of human services.Only additional and/or corrected information will be contained in this report.It was reported that a 2.0 mm drill bit/quick coupling/100 mm broke during a tissue grafting of the patella on (b)(6) 2017.The tip of the drill bit broke off in the patella and was left in the patient.Surgical delay and patient outcome is unknown.This report is for one (1) 2.0 mm drill bit.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: additional information/age & gender reported.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: 2.0MM DRILL BIT/QC/100MM
• Common Device Name: INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• MDR Report Key: 6805681
• Report Number: 3003506883-2017-10171
• Device Sequence Number: 1566510
• Product Code: HWE
• UDI-Device Identifier: 10886982186102
• UDI-Public: (01)10886982186102(10)4830748
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 07/26/2017

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 Lot Number: 4830748
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 11/20/2017
• 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: 61 YR