MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12.0MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE; NAIL,FIXATION,BONE

Model Number	03.010.437S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 or Problem Description
It was reported that on an unknown date, during an orthopedic procedure, part of the outer protection sleeve for supratellar tibial nail broke off during use.There were fragments generated from broken device.Surgeon tried to locate the broken off piece.The broken plastic fragment could not be obtained.The surgeon had to perform an arthrotomy of the knee to make sure it was not in the joint.There was a surgical delay of forty-five (45) minutes.The procedure was successfully completed.Patient status is unknown.Concomitant device reported: unk - handles: trauma (part # unknown, lot # unknown, quantity 1), unk - guide/sleeves/aiming: trauma (part # unknown, lot # unknown, quantity 1), unk - insertion instruments: trocar: tr (part # unknown, lot # unknown, quantity unknown).This report is for one (1) 12.0mm outer protection sleeve.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 12.0MM OUTER PROTECTION SLEEVE FOR SUPRAPATELLAR - STERILE
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8500875
• Report Number: 2939274-2019-57417
• Device Sequence Number: 2758827
• Product Code: JDS
• UDI-Device Identifier: 10886982068781
• UDI-Public: (01)10886982068781
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K111667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2019

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: 03.010.437S
• Device Catalogue Number: 03.010.437S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/10/2019
• 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