MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STRAIGHT TIP T15 DRIVER- STANDARD; SCREWDRIVERS

Catalog Number	03.632.055
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier reported as (b)(6).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Without a lot number, the device history records review could not be completed.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 during a transforaminal lumbar interbody fusion (tlif) on (b)(6) 2018, several instruments failed.When inserting a titanium cannulated screw into lumbar four (l4), the ratchet t-handle made a clicking sound and slipped against the t15 driver shaft.The surgeon determined it would not work and requested a different handle.The shaft was changed to another t-handle and surgeon completed inserting the screws just fine.Then, at the end of the case, the surgeon selected a transconnector and began locking it using the standard torque limiting handle and straight t15 driver shaft.The handle clicking as normal and torquing out, the driver shaft broke off into the recess of the transconnector.The surgeon removed the driver shaft and transconnector then requested another driver shaft and transconnector.Other items with same part number were obtained and tried again.This time, instead of the tip breaking, the tip of the shaft began to deform.Surgeon requested a third shaft and the torque limiter clicked as it should on all three (3) screws of the transconnector.Surgery was completed with a the three to five (3-5) minute delay to gather secondary instruments.There were no complications to the patient.Concomitant devices: screws (part: unknown, lot: unknown, quantity: 3); torque limiting handle (part: 03.632.204, lot: unknown, quantity: 1); titanium cannulated matrix screw (part: 04.616.745, lot: unknown, quantity: 1); t25 stardrive shaft for matrix (part: 03.632.003, lot: unknown, quantity: 1).This report is for a straight tip t15 driver- standard.This is report 1 of 2 for (b)(4).
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.Additional narrative: the device was received, the investigation is in progress, 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
This is report 2 of 3 for (b)(4).
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.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: STRAIGHT TIP T15 DRIVER- STANDARD
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8226657
• Report Number: 2939274-2019-55751
• Device Sequence Number: 1997869
• Product Code: HXX
• UDI-Device Identifier: 10705034719115
• UDI-Public: (01)10705034719115
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2018

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 Catalogue Number: 03.632.055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 01/03/2019; 02/06/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 01/30/2019; 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR