MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC HELICAL BLADE F/TFN Ø11 L90 TAN GOLD; ROD, FIXATION, INTRAMEDULLARY

Model Number	456.303
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown when the event occurred.(b)(4).This report is for helical blade/unknown lot.Lot number are unknown.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 patient had a revision on (b)(6) 2017, due to helical blade was sticking out.Patient was implanted with trochanteric fixation nail, date unknown.Patient began to have pain of the hip at the joint, x-ray was taken, date unknown, it was noticed that the helical blade was sticking out significantly lateral because the bone had collapsed.It was reported that the device functioned correctly by sliding and not cutting out the femoral head, but caused the patient pain on the lateral side of the hip.Helical blade was removed and a shorter was implanted.Concomitant device(s) reported: tfn nail (part # unknown, lot # unknown, quantity 1).This complaint involves one (1) device.This report is for 1 (one) helical blade.(b)(4).

• Brand Name: HELICAL BLADE F/TFN Ø11 L90 TAN GOLD
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19083
• MDR Report Key: 7154480
• Report Number: 2939274-2017-50483
• Device Sequence Number: 63474
• Product Code: HSB
• UDI-Device Identifier: 10886982226679
• UDI-Public: (01)10886982226679(10)UNKNOWNLOT
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2017

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: 456.303
• Device Catalogue Number: 456.303
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2017
• Initial Report FDA Received Date: 12/29/2017
• 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: 69 YR
• Patient Weight: 51