MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM TI CANCELLOUS POLYAXIAL SCREW 16MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	04.614.016
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code kwp, mnh, mni.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Device is not distributed in the united states but is similar to device marketed in the usa.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 screws inner shaft was stripped and hot holding adequately on the screwdriver.There was no reported delay and it was unknown if surgery was successful.There was no patient consequence.Concomitant device reported: unknown screwdriver (part# unknown, lot# unknown, quantity# 1).This is report 01 of 03 of (b)(4).
Event or Problem Description
It was reported that during an unknown procedure on (b)(6) 2020, the 3.5mm ti cancellous polyaxial screw's inner shaft was stripped and did not hold adequately on the screwdriver.There was no reported delay and it was unknown if surgery was successful.There was no patient consequence.No further information was provided.
Additional Manufacturer Narrative
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Updated event description, 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: 3.5MM TI CANCELLOUS POLYAXIAL SCREW 16MM
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9671701
• Report Number: 2939274-2020-00642
• Device Sequence Number: 2884820
• Product Code: NKG
• UDI-Device Identifier: 10705034738352
• UDI-Public: (01)10705034738352
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142838
• 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,Followup
• Report Date (Section B): 01/14/2020

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: 04.614.016
• Device Catalogue Number: 04.614.016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWDRIVERS