MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.0MM TRANSFIXATION PIN 225MM; APPLIANCE, FIXATION, NAIL

Model Number	294.950
Medical Device Problem Codes	Use of Device Problem (1670); Malposition of Device (2616)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt info: this information is unknown.User error occurred on (b)(6) 2018.This error led to patient¿s failure of reduction.Lot number is unknown.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.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.(b)(4).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 on (b)(6) 2018, the patient underwent a revision to remove the implanted transfixation pin since it missed the calcaneus when being implanted.This led to the patient's failure of reduction on the ankle.The removed pin was replaced with a new one which was positioned on the correct location on the ankle external fixator.The old pin was originally implanted on (b)(6) 2018, and was inserted using a drill with no guide.The surgery was successfully completed with no surgical delay reported.The patient was in stable condition.Concomitant device: drill (part: unknown, lot: unknown, quantity: 1).This report is for a 6 0 mm transfixation pin 225 mm.This is report 1 of 1 for (b)(4).

• Brand Name: 6.0MM TRANSFIXATION PIN 225MM
• Common Device Name: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7685122
• Report Number: 2939274-2018-52862
• Device Sequence Number: 16493322
• Product Code: KTT
• UDI-Device Identifier: 10886982182432
• UDI-Public: (01)10886982182432
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2018

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: 294.950
• Device Catalogue Number: 294.950
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 07/13/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR