MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC Ø8.2MM TI ADOLESCENT LAT ENTRY FEMORAL NAIL-EX/340MM/RT-STER; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.031.934S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional patient¿s identifier reported as (b)(6).Date of postoperative pain development is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6) a device history record (dhr) review was performed manufacturing location: monument, manufacturing date: 16-oct-2008, expiration date: 30-sep-2017: part #: 04.031.934s, lot#: 5891278 (sterile) - 08.2mm ti adolescent lat entry femoral nail-ex/340mm/rt-ster - sterile.Quantity 6.Component parts reviewed: raw material part no: 21012 bp 80, 5336099 - raw material received from supplier perryman company.Certified test report, certificate of test for ti received from allvac meet specification.Raw material inspection sheet and raw material receiving/putaway checklist meet requirements.Inspection sheet for in-process acceptance sheet, inspect dimensional, final inspection met inspection acceptance criteria.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.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 hardware removal of an adolescent nail was performed on (b)(6) 2018.The patient was initially implanted with one (1) adolescent nail and three (3) 4mm locking screws on (b)(6) 2017.After the implant, the patient started experiencing pain and believed that the pain was caused by the nail.Due to the pain, the patient was brought back to the operating room on (b)(6) and the nail was removed.The nail was not replaced with any new hardware.The removal surgery was successfully completed without any delay.The patient was reported to be fine at the end of the procedure.This report is for one (1) unknown ø8.2mm ti adolescent lat entry femoral nail-ex/340mm/rt-ster.This is report 1 of 2 for complaint (b)(4).

• Brand Name: Ø8.2MM TI ADOLESCENT LAT ENTRY FEMORAL NAIL-EX/340MM/RT-STER
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7433927
• Report Number: 2939274-2018-51730
• Device Sequence Number: 1717082
• Product Code: HSB
• UDI-Device Identifier: 10886982094322
• UDI-Public: (01)10886982094322
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K070843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: 04.031.934S
• Device Catalogue Number: 04.031.934S
• Device Lot Number: 5891278
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/16/2018
• 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: 11 YR
• Patient Weight: 50