MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.944S
Medical Device Problem Codes	Break (1069); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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
Device report from (b)(6) reports an event as follows: it was reported that a surgeon heard of a broken trochanteric fixation nail advanced (tfna) tfna nail.The nail had broken at the junction of the blade/nail.This report is for a 9mm/130 degree titanium (ti) cannulated tfna nail.This is report 1 of 1 for (b)(4).
Event or Problem Description
The initial complaint was reviewed and found not reportable as there is no event of a broken nail that can be identified.This report was hearsay and did not relate to any specific event.

• Brand Name: 9MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11655774
• Report Number: 2939274-2021-01826
• Device Sequence Number: 3498225
• Product Code: HSB
• UDI-Device Identifier: 10886982098047
• UDI-Public: (01)10886982098047
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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: 04.037.944S
• Device Catalogue Number: 04.037.944S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 06/10/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention