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
Product complaint # (b)(4).Additional narrative: investigation summary: customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided.The image(s) was reviewed, and the complaint condition could be confirmed since the distal tip is observed to have broken off.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: part: 317.820, lot: f-26148, manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: dec 13, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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) 2021, the patient underwent for a surgery for lower jaw fracture.During the surgery, while drilling the bone the drill gets split.It was unknown if the surgery completed successfully.The patient outcome was unknown.This complaint involves one (1) device.This report is for (1) implant inserter sh connection.This report is 1 of 3 (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.D2: additional procodes: dzi, erl, hbe.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: 11546130
• Report Number: 8030965-2021-02197
• Device Sequence Number: 19572122
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2021

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?: No
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1