MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 115MM STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.038.315S
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Discomfort (2330); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of femoral neck collapse and subsequent helical blade cutout is an unknown date between (b)(6) 2018.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review has been requested.Code (b)(4) used to capture surgical intervention and device removal.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) 2018, the patient was implanted with a trochanteric fixation nail system advance (tfna).The patient underwent implant removal on (b)(6) 2018 due to discomfort from lateral cut out from the helical blade.The femoral neck collapsed, forcing the blade to protrude laterally.The entire implant was removed and revised to a total hip arthroplasty.It was unknown if there was a surgical delay.Current patient status is unknown.Concomitant devices: 11mm/130 deg titanium cannulated tfna nail - sterile (part: 04.037.142s, lot: h059183, quantity: 1), distal locking screw (part: unknown, lot: unknown, quantity: 1) this report is for a tfna helical blade 115mm sterile this is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device history record (dhr) review: part number: 04.038.315s; lot number: 7943374; date of manufacture: 23 march 2015; place of manufacture: (b)(4); part expiration date: 28 february 2025; nonconformity noted: n/a.Description of dhr review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of trochanteric fixation nail advanced (tfna) helical blade 115mm sterile product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot 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 raw material device history record revealed this lot met all specifications with no non-conformity noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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.

• Brand Name: TFNA HELICAL BLADE 115MM 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: 7596628
• Report Number: 2939274-2018-52488
• Device Sequence Number: 10795764
• Product Code: HSB
• UDI-Device Identifier: 10886982099099
• UDI-Public: (01)10886982099099
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 04.038.315S
• Device Catalogue Number: 04.038.315S
• Device Lot Number: 7943374
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 07/11/2018
• 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
• Patient Age: 78 YR
• Patient Weight: 61