MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM TI HELICAL BLADE 115MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	456.308S
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: device was used for treatment, not diagnosis.(b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records: part number: 456.308s, lot number: 6652957, date of manufacture: 17 may 2011, (b)(4), part expiration date: 01 april 2020, nonconformance 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 11.0mm ti helical blade 115mm sterile product was processed through the normal manufacturing and inspection operations with no rework nor non-conformities 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-conformance 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.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.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 a trochanteric fixation nail (tfn) implant cut-out.The femoral head collapsed around the femoral neck and the helical blade cut into the pelvis.It required implant removal on (b)(6) 2018.There was no fall reported by patient.Concomitant device report: [5.0mm ti locking screw 42mm- for im nails] (part #:458.942, lot #: unknown, quantity: 1).This complaint is for one (1) device.(b)(4).

• Brand Name: 11.0MM TI 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: 7325798
• Report Number: 2939274-2018-50942
• Device Sequence Number: 1605577
• Product Code: HSB
• UDI-Device Identifier: 10886982226785
• UDI-Public: (01)10886982226785(17)200401(10)6652957
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2018

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: 04/01/2020
• Device Model Number: 456.308S
• Device Catalogue Number: 456.308S
• Device Lot Number: 6652957
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 03/08/2018
• 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: 84 YR
• Patient Weight: 74