MAUDE Adverse Event Report: DEPUY SPINE INC SKYLINE ANTERIOR CERVICAL PLATE SYSTEM DRILL 2.2 X 16MM; BIT, DRILL

Model Number	286820016
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/ investigation, but has yet to be received.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.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 on (b)(6) 2021 that the customer reported a broken drill.This report is for one (1) skyline anterior cervical plate system drill 2.2 x 16mm.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d4.G1.H3, h6: lot number is unknown, and therefore, device history record (dhr) review could not be completed.If the lot number can be confirmed, the dhr will be revisited.A manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure, no manufacturing record evaluation is required.Visual inspection: the sky 16mm drill flatt chuck was received at us customer quality (cq).Upon visual inspection, it was observed that the distal tip was broken and broken piece was not returned.There was also discoloration seen on the ring component of the device.No other issues were identified with the returned device.Dimensional inspection: the dimensional inspection of the device could not be conducted due to post-manufacturing damage.Document/specification review: since the exact manufactured date of the device was not identified, the current revision of drawings were reviewed.- 12mm, 14mm & 16mm drill, assembly prius acp conclusion: this complaint is confirmed for the sky 16mm drill flatt chuck.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined, it is possible that the device encountered unintended forces during its use.No new malfunctions were observed during this investigation.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 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.D9.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H6: part 286820016, lot ng26492: supplier: nginstruments.Release to warehouse date: february 23, 2011.No non-conformance reports (ncr's) were generated during production.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
Fragments were generated, removed and were discarded.The channel was already pre-drilled enough; the procedure was successfully completed with a five to ten minute delay.

• Brand Name: SKYLINE ANTERIOR CERVICAL PLATE SYSTEM DRILL 2.2 X 16MM
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11801430
• Report Number: 1526439-2021-00929
• Device Sequence Number: 4203413
• Product Code: HTW
• UDI-Device Identifier: 10705034215327
• UDI-Public: 10705034215327
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 04/14/2021

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: 286820016
• Device Catalogue Number: 286820016
• Device Lot Number: NG26492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 07/02/2021; 07/26/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 07/13/2021; 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1