MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MINIPOLYAXIAL SCREWDRIVER; SCREWDRIVERS

Model Number	288304000
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
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
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Reporter is a j&j sales representative.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 (b)(6) 2021, that the patient underwent for a surgery.During the surgery, the screwdrivers are stripping and getting stuck in screws.It was noticed in the poly screws and the final tightening time.It was unknown if the surgery completed successfully without delay.There were no patient consequences are reported.This complaint involves unknown number of devices.This report is for (1) mini polyaxial screwdriver.This report is 4 of 6 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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/ investigation.The complaint product is not returning.H3, h6: the investigation could not be completed, no conclusion could be drawn at the time of filing this report.The 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.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: MINIPOLYAXIAL SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11952596
• Report Number: 1526439-2021-01156
• Device Sequence Number: 4243047
• Product Code: HXX
• UDI-Device Identifier: 10705034221298
• UDI-Public: 10705034221298
• 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): 05/12/2021

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: 288304000
• Device Catalogue Number: 288304000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 06/30/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MINIPOLYAXIAL SCREWDRIVER; MINIPOLYAXIAL SCREWDRIVER; MINIPOLYAXIAL SCREWDRIVER; MINIPOLYAXIAL SCREWDRIVER; MINIPOLYAXIAL SCREWDRIVER; UNKNOWN SCREWS; X15 TORQUE DRIVER; X15 TORQUE DRIVER; X15 TORQUE DRIVER