MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI END CAP T40 STRDRV 5MM EXT FOR ADOLESCENT LFN-EX; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.031.001
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned and no lot number was provided.Based on the information available, 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.Code (b)(4) used to capture surgical delay of ten to fifteen (10-15) minutes.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) 2018, the patient underwent implantation of an adolescent lateral-entry femoral nail (alfn).During the procedure, the surgeon struggled to thread the titanium (ti) end cap t40 stardrive 5mm ext for adolescent lfn-ex into the end of the nail, as well as to get the end cap to fully seat to its appropriate depth.The surgeon decided to remove the end cap and did not use any replacement in the nail.Upon inspecting the threads of the end cap after it was removed, the scrub technician noticed the threads were a little damaged.It is unknown if this damage occurred before the surgeon tried inserting the end cap into the nail or as a result of the surgeon trying to insert it into the nail.The procedure was completed successfully, with a reported delay of ten to fifteen (10-15) minutes.Patient status was stable.Concomitant device: alfn (part: unknown, lot: unknown, quantity: 1) this report is for a ti end cap t40 strdrv 5mm ext for adolescent lfn-ex.This is report 1 of 1 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.
Event or Problem Description
Further it was reported that although the threads of the titanium end caps were damaged, there were no fragments generated.The end cap was easily removed from the patient without any additional medical intervention.

• Brand Name: TI END CAP T40 STRDRV 5MM EXT FOR ADOLESCENT LFN-EX
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7682110
• Report Number: 2939274-2018-52849
• Device Sequence Number: 1369772
• Product Code: HSB
• UDI-Device Identifier: 10886982093806
• UDI-Public: (01)10886982093806
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K070843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2018

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 Model Number: 04.031.001
• Device Catalogue Number: 04.031.001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 07/26/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: (B)(6) 2018