MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DRILL STOP FOR 4.5MM/6.5MM STEPPED DRILL BIT; MISC ORTHO SURGICAL INSTR

Model Number	03.010.079
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event year is reported as 2020; however exact date of event is unknown.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was 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 an unknown date, the patient underwent for an intramedullary nailing of femur surgery.During the surgery, the drill stop was slide twice in the same procedure.The surgery was completed successfully without delay reported.There were no patient consequences.Concomitant device reported: drill bit (part#: 03.010.078, lot#: unknown, quantity: 1), unknown screw (part#: 03.010.078, lot#: unknown, quantity: 2).This complaint involves one (1) device.This report involves one (1)drill stop for 4.5mm/6.5mm stepped drill bit.This is report 1 of 1 (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: d11: additional concomitant device reported.E1: reporters state: british columbia h6: investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.H11: d9: complainant part is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: DRILL STOP FOR 4.5MM/6.5MM STEPPED DRILL BIT
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11247381
• Report Number: 2939274-2021-00537
• Device Sequence Number: 3976851
• Product Code: LXH
• UDI-Device Identifier: 10886982067494
• UDI-Public: (01)10886982067494
• 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): 01/08/2021

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: 03.010.079
• Device Catalogue Number: 03.010.079
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 02/22/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM; 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM; DRILL STOP FOR 4.5MM/6.5MM STEPPED DRILL BIT; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM; UNK - SCREWS: TRAUMA