MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; SCREW, FIXATION, BONE

Device Problems Dull, Blunt (2407); Separation Failure (2547)

Patient Problem No Code Available (3191)

Event Date 05/09/2018

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown locking screw/unknown lot.Part and lot number are unknown; udi number is unknown.Original implant date is unknown.Explanted date: unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(510k): unknown, as specific part and lot numbers for locking screw is not provided.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 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.The plate was not successfully removed.There was a surgical delay for approximately forty (40) minutes.The surgeon closed the incision.The plate removal was done on unknown date using a saw in another facility.In addition, the patient status was reported stable.This report addresses issue of a locking screw fused into the plate, therefore the plate could not be removed.The intraoperative issue of conical extractor breakage is captured under linked complaint (b)(4).This report is for one (1) unknown locking screw.This is report 2 of 2 for complaint (b)(4).

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7579262
• MDR Text Key: 110445374
• Report Number: 2939274-2018-52430
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 06/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR