MAUDE Adverse Event Report: SYNTHES ELMIRA TFNA HELICAL BLADE 95MM STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.038.295S

Device Problem Unintended Movement (3026)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Date of device migration and non-union is not known (b)(4).(b)(6).Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review for part # 04.038.295s lot # h313086.Release to warehouse date: 05 may 2017.Expiration date: 31 march 2027.(b)(4).Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna helical blade 95mm 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.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 Description

It was reported that a trochanteric fixation nail-advanced (tfna) hardware removal with revision due to proximal femur non-union was performed on (b)(6) 2017.The date of the original procedure is unknown; it was performed approximately six months prior.Subsequently the patient complained of pain and it was discovered that the helical blade penetrated the femoral head and migrated into the acetabulum.Removed hardware included: one (1) trochanteric nail, one (1) helical blade and one (1) distal locking screw.All explanted hardware was removed intact.The fracture site was re-reamed and a new nail was implanted with bone graft into the defect, a new lag screw and two (2) distal locking screws.It was noted that the patient has poor bone quality.Cultures were taken and results are pending.There were no signs of infection present.The procedure was completed successfully with the patient in stable condition.There was no surgical delay.Concomitant devices reported: 12mm 130 degree cannulated tfna nail 420mm-left (04.037.263s, lot h258920, quantity 1), 5.0mm locking screw for im nail (04.005.532s, lot h053680, quantity 1).This report is for one (1) tfna helical blade.(b)(4).

• Brand Name: TFNA HELICAL BLADE 95MM STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6974700
• MDR Text Key: 90166730
• Report Number: 3003506883-2017-10247
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.295S
• Device Lot Number: H313086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 76