MAUDE Adverse Event Report: DEPUY SPINE INC T27 MODULAR DRIVER SHAFT; SCREWDRIVERS

Model Number	279763010
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: reporter is jnj 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 on an unknown date that the patient underwent for a screw removal procedure in the iliac performed on (b)(6) 2020.During screw removal, a driver¿s tip stripped and remain in the patient body.The surgery was completed without delay reported.No adverse effect to the patient was reported.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity unknown) unknown setscrews (part# unknown, lot# unknown, quantity unknown).This complaint involves two (2) devices.This report is for (1) t27 modular driver shaft.This is report 1 of 1 for (b)(4).Related product complaint: (b)(4).

• Brand Name: T27 MODULAR DRIVER SHAFT
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10351455
• Report Number: 1526439-2020-01425
• Device Sequence Number: 19483884
• Product Code: HXX
• UDI-Device Identifier: 10705034200682
• UDI-Public: 10705034200682
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2020

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: 279763010
• Device Catalogue Number: 279763010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 07/31/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; UNKNOWN SCREWDRIVERS; VIPER TI SAI POLY 10X110MM