MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI TROCHANTERIC REATTACHMENT DEVICE W/CABLES/STANDARD-STER; CERCLAGE FIXATION

Model Number	498.806S
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	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.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.(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 during an unknown procedure on an unknown date, the surgeon had difficulty with a trochanteric reattachment device.The surgeon was unsure how to use the trochanteric attachment device and tried to use it on his own unsuccessfully.The device was removed from the patient.The procedure and patient outcome is unknown.Patient was scheduled for a follow up surgery on another date.This report is for a titanium (ti) trochanteric reattachment device with cables.This is report 1 of 1 for (b)(4).

• Brand Name: TI TROCHANTERIC REATTACHMENT DEVICE W/CABLES/STANDARD-STER
• Common Device Name: CERCLAGE FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8240779
• Report Number: 2939274-2019-55796
• Device Sequence Number: 19380537
• Product Code: JDQ
• UDI-Device Identifier: 10886982236975
• UDI-Public: (01)10886982236975
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K001709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2018

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 Model Number: 498.806S
• Device Catalogue Number: 498.806S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention