MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 90MM STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.290S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Date when non-union began is unknown device is not expected to return.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.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 underwent a right open reduction internal fixation (orif) of a proximal femur fracture using a trochanteric fixation nail - advance (tfna) on (b)(6) 2017.Postoperatively, a non-union was identified on a routine follow-up x-ray.Patient was asymptomatic (no complaints of pain or discomfort).The patient did not heal due to lateral cortex portion of the femur bone was missing because of the complex fracture pattern.The patient underwent a revision on (b)(6) 2018 and received a right total hip replacement.All the removed implants were intact.There were no issues during the revision and no surgical time delay.The patient status was stable.This is report 1 of 3 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Lot number available; the investigation could not be completed; no conclusion could be drawn, as no product was received.Device history record review: part number: 04.038.290s, lot number: h263442, date of manufacture: 23 january 2017, place of manufacture: (b)(4), part expiration date: 31 december 2026, 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 tfna helical blade 90mm 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-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.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 90MM 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: 7440457
• Report Number: 2939274-2018-51807
• Device Sequence Number: 13743300
• Product Code: HSB
• UDI-Device Identifier: 10886982098993
• UDI-Public: (01)10886982098993
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2018

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 Expiration Date: 02/28/2026
• Device Model Number: 04.038.290S
• Device Catalogue Number: 04.038.290S
• Device Lot Number: H263442
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 04/18/2018
• 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