MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 105MM - STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	04.038.405S
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Failure of Implant (1924); 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.Part number: 04.038.405s.Lot number: h477539.Part manufacture date: 20 november 2017.Manufacturing location: (b)(4).Part expiration date: 31 october 2027.Nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna fenestrated helical blade 105mm was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.The lot quantity of (b)(4) pieces met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the device history record for the raw material revealed no complaint related anomalies.The device history record shows this lot met all requirements at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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.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) 2020 the patient underwent the removal of a protruding proximal femoral nailing system (tfna) fenestrated helical blade.It was revised to a shorter screw implant.The patient was okay.(b)(4) captures the post op event the removal of protruding proximal femoral nailing system (tfna) fenestrated helical blade and (b)(4) captures the intra op event wherein during revision surgery the screw inserter was not functioning properly due to damaged threads.Concomitant devices reported: unknown (tfna) nail (part# unknown, lot# unknown, quantity 1), unknown locking screw (part# unknown, lot# unknown, quantity 1).This report is for 1 tfna fenestrated helical blade 105mm - sterile.This is report 1 of 1 for (b)(4).

• Brand Name: TFNA FENESTRATED HELICAL BLADE 105MM - STERILE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10339949
• Report Number: 2939274-2020-03325
• Device Sequence Number: 3748751
• Product Code: KTT
• UDI-Device Identifier: 10886982099310
• UDI-Public: 10886982099310
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/08/2020

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: 04.038.405S
• Device Catalogue Number: 04.038.405S
• Device Lot Number: H477539
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/29/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention