MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM DRILL BIT/QC WITH 65MM STOP; BIT,DRILL

Catalog Number	388.394
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 to treat cervical damage.During the surgery, while the surgeon was adjusting screw insertion direction against the hardened bone, the drill bit tip¿s breakage.The fragmented tip was removed from the patient¿s body.Also, the torque limitation handle became out of order during rod deployment.The procedure was completed less than 30-minute surgical delay.No further information is available.Concomitant device reported: unknown screw -spine: (part# unknown; lot# unknown; quality:1).This complaint involves two (2) devices.This report is for one (1) 2.4mm drill bit/qc with 65mm stop.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H10 additional narrative: h3, h6: investigation summary the product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that drill bit 2.4 w/stop 2flute was broken, and broken piece was also returned no other issues were identified.No new additional information can be added.The dimensional inspection was performed, and it is within the specification limit.The observed condition drill bit 2.4 w/stop 2flute in the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed broken condition of the drill bit 2.4 w/stop 2flute.While no definitive root cause could be determined, it is probable that the drill bit 2.4 w/stop 2flute was broken due to the application of unintended forces during usage.There was no indication that a design or manufacturing issue contributed to the complaint.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 history lot part #: 388.394.Lot #: u141025.Manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: 26 jan 2012.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances 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.

• Brand Name: 2.4MM DRILL BIT/QC WITH 65MM STOP
• Common Device Name: BIT,DRILL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12681869
• Report Number: 8030965-2021-08889
• Device Sequence Number: 3751177
• Product Code: HTW
• UDI-Device Identifier: 07611819752931
• UDI-Public: 07611819752931
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2021

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 Catalogue Number: 388.394
• Device Lot Number: U141025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HANDLE W/TORQ LIMIT 2NM W/QUICK-COUPL; UNKNOWN SCREW -SPINE
• Patient Sex: Unknown