MAUDE Adverse Event Report: SYNTHES GMBH 1.5MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	317.82
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procodes: dzi, erl, hbe.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 (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2021, the drill bit broke.This report is for a 1.5mm drill bit/mini qc with 12mm stop/44.5mm.This is report 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.H3, h4, h6: part: 317.820, lot: f-26148, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 13 dec 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the 1.5mm drill bit/mini qc with 12mm stop/44.5mm (p/n: 317.820, lot #f-26148) was returned and received at us customer quality (cq).Upon visual the drill bit tip iwas broken, and the broken pieces were not returned.No other issues were identified with the returned components of the device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed current & manufactured were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Investigation conclusion the complaint condition is confirmed for the 1.5mm drill bit/mini qc with 12mm stop/44.5mm (p/n: 317.820, lot #f-26148).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 1.5MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11589441
• Report Number: 8030965-2021-02440
• Device Sequence Number: 14647896
• Product Code: HWE
• UDI-Device Identifier: 10887587038773
• UDI-Public: (01)10887587038773
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K043310
• 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): 03/02/2021

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: 317.82
• Device Catalogue Number: 317.820
• Device Lot Number: F-26148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1