MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED 3.5MM HEXAGONAL SCREWDRIVER

Model Number	314.19
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Without a valid lot number the device history records review could not be completed.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is j&j company representative.The investigation could not be completed.No conclusion could be drawn, as no product was received.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 reported that on unknown date, the screwdriver was twisted.It is unknown if there were patient and procedure involvement.This complaint involves one (1) device.This report is for one (1) cannulated 3.5mm hexagonal screwdriver.This report is 1 of 1 for (b)(4).

• Brand Name: CANNULATED 3.5MM HEXAGONAL SCREWDRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11896298
• Report Number: 2939274-2021-02649
• Device Sequence Number: 1389607
• Product Code: HXX
• UDI-Device Identifier: 10886982188663
• UDI-Public: (01)10886982188663
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2021

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: 314.19
• Device Catalogue Number: 314.19
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1