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 Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	05/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is an instrument and is 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.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 patient underwent a removal of a pediatric osteotomy plate on (b)(6) 2018.The plate removal was a patient¿s choice after a successful healing.During the procedure, there was a locking screw fused into the plate and when the surgeon attempted to remove the screw, the head stripped.The conical extractor was then used but it broke inside the screw.The surgeon wanted to saw the plate to separate it from the screw; however, there was no saw available in the hospital; thus, the patient¿s incision site was closed after about forty-five (45) minutes of trying to remove the plate.Reportedly this event resulted in a forty (40) minute surgical delay.The patient was reported as stable and in good condition.The plate removal was done on unknown date using a saw in another facility.This report is for the conical extraction screw.The plate and screw will be captured under related complaint (b)(4).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.Patient ethnicity is unknown.Code 3191 used to capture forty (40) minute surgical delay.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: 7577972
• Report Number: 2939274-2018-52427
• Device Sequence Number: 19458191
• Product Code: FSM
• UDI-Device Identifier: 10705034771083
• UDI-Public: (01)10705034771083
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 05/09/2018
• Supplement Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR