MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 15.0MM CANN FLEXIBLE DRILL BIT LARGE QC/310MM

Model Number	03.010.165
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.The device was received, the investigation is in progress, 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.During the surgery, the drill bit was broken while insertion.There was no fragment generated.The surgery was completed successfully without delay.There were no patient consequences are reported.This complaint involves one (1) device.This report is for (1) 15.0mm cann flexible drill bit large qc/310mm.This report is 1 of 1 for (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.H3, h6: investigation summary.Investigation flow: damage.Visual inspection: the drill bit ø15 cann flex l250 (part #: 03.010.165, lot #: unk) was received at us cq.Upon visual inspection, it was observed that the drill bit shaft was cracked at the proximal end of the shaft section.The shaft was not completely broken into two pieces.No other issues were identified with the returned device.The device failure/defect was identified.Document/specification review: based on the date of manufacture the following drawings, reflecting the manufactured and current revision were reviewed.The complaint was confirmed.Investigation conclusion: the complaint condition was confirmed as the shaft of the device was cracked.There was no indication that a design or manufacturing issue has caused the breakage and hence the root cause cannot be determined.However, it is possible the device experienced an application of unintended forces, causing the reported condition.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 #: 03.010.165.Lot #: unknown.Since lot # is unknown , a manufacturing record evaluation was performed for the received device.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: 15.0MM CANN FLEXIBLE DRILL BIT LARGE QC/310MM
• Common Device Name: DRILL BIT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11494760
• Report Number: 2939274-2021-01319
• Device Sequence Number: 2843466
• Product Code: HTW
• UDI-Device Identifier: 10886982068002
• UDI-Public: (01)10886982068002
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 02/16/2021

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: 03.010.165
• Device Catalogue Number: 03.010.165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1