MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE; NAIL,FIXATION,BONE

Model Number	04.004.443S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 (b)(6) 2020, the connecting screw, cannulated with internal thread was very difficult to disengage from expert tibial nail, cannulated at the end of surgery.Vice grips were used and attached to the ball screwdriver to allow for enough leverage to disengage the connecting bolt.No fragments were generated.There was no surgical delay.The procedure successfully completed.No patient consequence.Concomitant devices reported: screwdrivers (part number unknown, lot unknown, quantity unknown), cann connecting scr w/internl thrd f/percutan insertn handle (part number 03.010.146, lot unknown, quantity 1).This report involves one (1) 10mm ti cannulated tibial nail-ex/315mm-sterile.This is report 1 of 2 for (b)(4).

• Brand Name: 10MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9968897
• Report Number: 2939274-2020-01888
• Device Sequence Number: 2437212
• Product Code: JDS
• UDI-Device Identifier: 10886982084170
• UDI-Public: (01)10886982084170
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.004.443S
• Device Catalogue Number: 04.004.443S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/16/2020
• Patient Sequence Number: 1