MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9 MM / TI CANN FRN / GT 380MM / RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.033.968S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2021
Type of Reportable Event	Malfunction
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.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) 2021, during femoral recon nail (frn) insertion, the frn nail became stuck in the canal requiring forceful impaction and subsequent extraction.The driving cap/threaded broke off.During the extraction of the frn nail, the two (2) universal chuck with t-handle broke due to forceful extraction.Action taken when the event occurred was extraction of nail, new ream rod inserted and same frn nail was inserted into femur.There was sixty (60) minutes surgical delay.The procedure was completed successfully.This report is for one (1) 9 mm / ti cann frn / gt 380mm / right - sterile.This is report 4 of 4 for complaint (b)(4).

• Brand Name: 9 MM / TI CANN FRN / GT 380MM / RIGHT - STERILE
• Common Device Name: 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: 11579149
• Report Number: 2939274-2021-01549
• Device Sequence Number: 14519719
• Product Code: HSB
• UDI-Device Identifier: 10886982272232
• UDI-Public: (01)10886982272232
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.033.968S
• Device Catalogue Number: 04.033.968S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2021
• Initial Report FDA Received Date: 03/27/2021
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 35