MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM CANNULATED DRILL BIT/QC 160MM; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

Model Number	310.67
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: gfa, gff, hsz.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on (b)(6) 2020 during a compact foot av procedure, 3.5 cannulates were used in which only one (1) 2.7 drill bit came and it was blunt.The surgeon passed one (1) guide of 1.25 and proceeded to drill but due to the lack of sharpness the needle bent.Another guide was requested and it was commented that the surgeon had to use strong force and that may have caused the guide to break.Fragments were generated ad a part remained inside the patient.There was a surgical delay of thirty (30) minutes.The procedure was successfully completed with the use of another drill.This report is for one (1) 2.7mm cannulated drill bit/qc 160mm.This is report 3 of 3 for (b)(4).
Event or Problem Description
Additional event information : the reported issue did not caused any impact to the patient.There was no additional intervention schedule to remove broken pieces from the patient.The mentioned needle that was bent is refers to the guidewire.The patient outcome was good.
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.Product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device history lot a dhr file for part #310.670, lot #f-25644 combination could not be found in the synthes systems.If more information becomes available this dhr review will be revisited.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: 2.7MM CANNULATED DRILL BIT/QC 160MM
• Common Device Name: INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10774686
• Report Number: 8030965-2020-08505
• Device Sequence Number: 19804378
• Product Code: HWE
• UDI-Device Identifier: 10886982186898
• UDI-Public: (01)10886982186898
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 310.67
• Device Catalogue Number: 310.670
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 12/01/2020
• 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: GUIDEWIRE Ø1.25 W/THREAD-TIP W/TROCAR L1; UNK - GUIDE/COMPRESSION/K-WIRES; GUIDEWIRE Ø1.25 W/THREAD-TIP W/TROCAR L1; UNK - GUIDE/COMPRESSION/K-WIRES
• Patient Age: 57 YR
• Patient Weight: 76