MAUDE Adverse Event Report: DEPUY SPINE INC 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).Additional narrative: 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 1 of 6 for (b)(4).

• Brand Name: MINIPOLYAXIAL SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11952592
• Report Number: 1526439-2021-01153
• Device Sequence Number: 4243046
• 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
• Report Date (Section B): 05/13/2021

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/07/2021
• Patient Sequence Number: 1