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 Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown.Lot number is unknown.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter phone number and email address are unknown.Without a lot number the device history records review could not be completed.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 the titanium (ti) cancellous expansion head screw broke during an anterior cervical discectomy (acd) procedure on (b)(6) 2018.During the procedure, one of the fins popped off as the surgeon went to bring the screw down flush with the plate.The second fin also popped off in trying to retrieve the first fin.When a conical screw extractor was used, the tip of the extractor broke off.The surgeon then used non-synthes surgical drill and burred the screw down to be flush with the plate.The screw was left behind the patient.It is unknown if there was a surgical delay.Patient outcome is unknown.Concomitant devices: spine plate (part: unknown, lot: unknown, quantity: 1); surgical drill (part: unknown, lot: unknown, quantity: 1).This report is for a conical extraction screw.This is report 2 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.Patient id: (b)(6).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 noted the surgeon then used metal cutting burs and burred the screw down to be flushed with the plate.The fragments generated from the broken device were easily and completely removed.No other medical intervention required.There was a twenty (20) minute delay in the procedure from cleaning out and checking out if there were still fragments in the patient and securing the implant.The patient was stable and the procedure was successfully completed.Updated to concomitant devices reported: metal cutting burs (part# unknown, lot# unknown, quantity# unknown).

• 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: 7635538
• Report Number: 2939274-2018-52617
• Device Sequence Number: 19281296
• Product Code: FSM
• UDI-Device Identifier: 10705034771083
• UDI-Public: (01)10705034771083
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: (B)(6) 2018