MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM DRILL BIT WITH 16MM STOP QC; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

Model Number	03.617.916
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.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
It was reported that on (b)(6) 2019, during anterior cervical decompression and fusion, while drilling through an unknown zero-p natural plate, the tip of the drill bit broke off and the broken fragment was retrieved immediately.The surgery was completed successfully with no harm to the patient reported.There was another drill bit used to complete the procedure.It was unknown if there was surgical delay.Concomitant device reported: unknown zero-p plate (part# unknown, lot# unknown, quantity 1).This report is for one (1) 2.0mm drill bit with 16mm stop qc.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.H3, h4, h6 investigation summary.Visual inspection: the 2.0mm drill bit with 16mm stop qc (p/n: 03.617.916, lot number: 8857942) was received at us cq.Visual inspection of the complaint device showed the drill bit had broken partway through the flutes.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post manufacturing damage.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the drill bit has broken partway through the flutes.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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: part: 03.617.916-us.Lot: 8857942.Manufacturing site: bettlach.Release to warehouse date: 28.Feb.2014.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.
Event or Problem Description
Updated event.The surgery was delayed for less than a minute.The surgeon was able to retrieve the tip of the broken drill bit almost immediately and the surgery was able to continue.

• Brand Name: 2.0MM DRILL BIT WITH 16MM STOP QC
• Common Device Name: INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9565905
• Report Number: 2939274-2020-00094
• Device Sequence Number: 2224028
• Product Code: HWE
• UDI-Device Identifier: 10705034717234
• UDI-Public: (01)10705034717234
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

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: 03.617.916
• Device Catalogue Number: 03.617.916
• Device Lot Number: 8857942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 01/31/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - CAGE/PLATE: ZERO-P
• Patient Age: 49 YR
• Patient Weight: 107