MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CONICAL EXTRACTION SCREW; TRAY,SURGICAL INSTRUMENT

Catalog Number	387.34
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient height reported as (b)(6).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient had a planned removal of a competitor¿s hardware (screws) on (b)(6) 2018.During the procedure, the surgeon removed one screw without difficulty.When he attempted to remove the second screw he was having difficulty.Therefore, the surgeon used the conical extraction screw.During removal, the tip of the extraction screw broke off into the screw and the implanted screw head popped off.The fragment was retrieved from the patient.The surgeon attempted to use a hollow reamer to remove the screw shaft and the teeth fell off of the hollow reamer into the patient.Those fragments were not retrieved.It appeared the retained shaft of the screw was fused with the patient¿s bone.The malfunction of the competitor¿s screw led to additional surgical intervention.This was less than a desirable outcome.The patient was stable following surgery.Surgeon stated that a 4.0mm cannulated hexagonal screwdriver got twisted during the surgery.It is unknown how or when the device twisted.Concomitant medical products: hollow reamer complete for 6.5mm & 7.0mm screws (309.065, lot number unknown, quantity 1), spare reamer tube for hollow reamer (309.480, lot number unknown, quantity 1).This report is for one (1) conical extraction screw.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Dhr review was completed.Part # 387.34 , synthes lot # u255107 , supplier lot # u255107 , release to warehouse date: 31 jan 2017 , supplier: (b)(4).No ncr¿s were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: CONICAL EXTRACTION SCREW
• Common Device Name: TRAY,SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7267026
• Report Number: 2939274-2018-50608
• Device Sequence Number: 2378303
• Product Code: FSM
• UDI-Device Identifier: 10705034771083
• UDI-Public: (01)10705034771083(10)U255107
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 01/22/2018

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: 387.34
• Device Lot Number: U255107
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 03/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 60