MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 11.0MM TI HELICAL BLADE 85MM; ROD,FIXATION,INTRAMEDULLARY

Model Number	456.302
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.Date of event is unknown.Additional classification code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.A device history record review was performed for the subject device part number: 456.302 lot number: 9887290.Date of manufacture: 31 august 2015.Place of manufacture: (b)(4).Part expiration date: n/a.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 11.0 mm ti helical blade 85 mm 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-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.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 a patient will have to undergo a revision surgery on (b)(6) 2018 for removal of a tfn nail, a helical blade and one 5.0 mm distal locking screw due to non-union.The hardware was implanted for treatment of proximal femur fracture on (b)(6) 2015.The revision surgery took place on (b)(6) 2018.It was an exchange nailing for nonunion of an atypical subtrochanteric femur fracture.One 11 mm/130 deg ti cann troch fixation nail 340 mm/right-ster and 11.0 mm ti helical blade 85 mm were removed intact without any complication.After the removal of the hardware, another 14 mm/130 deg ti cann troch fixation nail 340 mm/right-ster, one 11.0 mm ti helical blade 85 mm and one 5.0 mm ti locking screw 48 mm-for im nails were implanted in the patient.Additionally, the surgeon used bone marrow aspirate concentrate and cancellous chip graft.The patient was stable after the surgery.There was no surgical delay and the procedure was completed successfully.As per the sales consultant the 5.0 mm distal locking screw implanted on (b)(6) 2015 was removed during a intervening surgery done on an unknown date between (b)(6) 2015 and (b)(6) 2018 in an attempt to dynamize the construct to induce callus formation and subsequent healing.This is report 2 of 2 for (b)(4).

• Brand Name: 11.0MM TI HELICAL BLADE 85MM
• 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: 7253269
• Report Number: 2939274-2018-50563
• Device Sequence Number: 19091570
• Product Code: HSB
• UDI-Device Identifier: 10886982226655
• UDI-Public: (01)10886982226655(10)9887290
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 456.302
• Device Catalogue Number: 456.302
• Device Lot Number: 9887290
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/08/2018
• 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