MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HELICAL BLADE COUPLING SCREW; MISC ORTHO SURGICAL INSTR

Catalog Number	357.377
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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, patient underwent surgery an initial trochanteric fixation nail.Intraoperative during the implantation of an unknown helical blade into the patient, the proximal end of both the helical blade inserter and helical blade coupling screw broke off.The broken pieces from both devices broke off at the same time and fell onto the floor.There were no fragments from either device that fell into the patient.The surgeon attached a universal chuck with t-handle to the remaining portion of the coupling screw to finish implanting the helical blade.The entire helical blade was fully implanted into the patient.There was no malfunction with the helical blade or universal chuck with t-handle.There was about a few minutes delay in the surgery.The procedure was completed successfully, with only a few minutes delay in surgery.There was no patient harm.The patient remained in stable condition.Concomitant devices reported: universal chuck with t-handle (part# 393.10, lot# unknown, quantity 1) ; nail head elem- tfn helical blade (part# unknown, lot# unknown, quantity 1) ; impaction inst: hammer/mallet- tr (part# unknown, lot# unknown, quantity 1) ; this report is for one (1) helical blade coupling screw.This is report 2 of 2 for (b)(4).

• Brand Name: HELICAL BLADE COUPLING SCREW
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7437608
• Report Number: 2939274-2018-51780
• Device Sequence Number: 1417055
• Product Code: LXH
• UDI-Device Identifier: 10886982196088
• UDI-Public: (01)10886982196088
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2018

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: 357.377
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2018
• Initial Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1