MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 3.5MM CANNULATED DRILL BIT/QC 160MM; BIT,DRILL

Model Number	310.68
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2021
Type of Reportable Event	Malfunction
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 is remains with a portion of the guide as it was not possible to remove it.Also, two drill bits have no edge.It was unknown if the surgery completed successfully.The patient outcome is unknown.This complaint involves (4) devices.This report is for (1) 3.5mm cannulated drill bit/qc 160mm.This report is 1 of 3 for (b)(4).
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
It was noted there was a surgical delay of unknown length.The procedure was completed successfully with no medical intervention required.
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.H3, h4, h6: part 310.680, lot f-31666: manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: february 05, 2021.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.H3, h6: a product investigation was completed: upon visual inspection, it is observed that the distal tip of the device was deformed.Rest of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.A functional assessment was not able to perform on the complaint device, as the device was received without relevant mating device.However, the deformed condition of the complaint device might have caused the complaint condition.Dimensional inspection showed the relevant dimensions were conforming.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed; no design issues or discrepancies were identified.This complaint is confirmed for the complaint device as the device was received with deformed distal tip.The potential cause for the complaint condition could be the deformed distal tip.No definitive root cause could be determined based on the provided information.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 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: 3.5MM CANNULATED DRILL BIT/QC 160MM
• Common Device Name: BIT,DRILL
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13085376
• Report Number: 8030965-2021-10461
• Device Sequence Number: 12190339
• Product Code: HTW
• UDI-Device Identifier: 10886982186911
• UDI-Public: (01)10886982186911
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 310.68
• Device Catalogue Number: 310.680
• Device Lot Number: F-31666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/27/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 12/24/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2021
• 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: 2.7MM CANNULATED DRILL BIT QC 160MM; 3.5MM CANNULATED DRILL BIT QC 160MM; UNK - GUIDES/SLEEVES/AIMING: GUIDE
• Patient Sex: Male