MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PEDIATRIC LCP HIP PLATE 3.5MM/130°/5 HOLES; PLATE, FIXATION, BONE

Model Number	02.108.331
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: hwc, jds complainant part is not expected to be returned for manufacturer review/investigation.Patient code (b)(4) used to capture additional medical/surgical intervention required.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.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) pediatric lcp hip plate 3.5mm/130°/5 holes.This is report 1 of 2 for complaint (b)(4).

• Brand Name: PEDIATRIC LCP HIP PLATE 3.5MM/130°/5 HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7579272
• Report Number: 2939274-2018-52428
• Device Sequence Number: 19213313
• Product Code: HRS
• UDI-Device Identifier: 10886982029874
• UDI-Public: (01)10886982029874
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K112085
• 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): 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 Model Number: 02.108.331
• Device Catalogue Number: 02.108.331
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 06/07/2018
• 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