MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - END CAPS: ALFN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNK - END CAPS: ALFN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable this report is for one (1) unknown end caps: alfn: / part and lot numbers are unknown.Without the specific part and lot number, the udi is not available.Complainant part is not expected to be returned for manufacturer review/investigation.Health effect / infection: impact code / surgical intervention: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on (b)(6) 2021, patient underwent removal of expert adolescent lateral femoral nail due to infection.Patient outcome was unknown.This complaint involves four (4) devices.This report is for one (1) unk - end caps: alfn.This report is 3 of 4 for (b)(4).

• Brand Name: UNK - END CAPS: ALFN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11621740
• MDR Text Key: 245493632
• Report Number: 2939274-2021-01713
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - END CAPS: ALFN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: UNK - END CAPS: ALFN; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; Ø8.2MM TI ADLES LAT ENT FMRL NAIL-EX/400MM/LT-STER
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR