MAUDE Adverse Event Report: SYNTHES ELMIRA 11.0MM TI HELICAL BLADE 90MM; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 456.303

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/08/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: additional device product code is hwc.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.The subject device has been received and is currently in the evaluation process.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture: dec 27, 2016.The review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 11.0mm ti helical blade 90mm non 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.

Event Description

It was reported that the during a trochanteric fixation nail (tfn) procedure, the helical blade would not go through the nail.As the blade was being hammered it would not go in through the nail.The surgeon removed the blade and nail and tried the blade/nail insertion at the back table and again it would not work.It was discovered that the aiming arm being used was incorrect.The nail is a 130 degree nail and the aiming arm used was 125 degree aiming arm.The surgeon did not want to use the same implants as he believed they were damaged during the failed blade insertion attempt.A new nail and blade were used to complete the procedure.The reported event resulted in a 10 minute surgical delay.The surgery was completed successfully with no harm to the patient.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the aiming arm was not returned for investigation.The returned nail was found to have the locking mechanism deployed.Because of this the helical blade was unable to pass through the nail.The proximal locking hole on the nail has damage around both surfaces, which is likely related to use of the incorrect aiming arm and attempting to force the blade into the nail.The returned blade has surface wear which is located distal to the neck, which is consistent with attempting to insert a blade into a nail with the locking mechanism already deployed.A visual inspection, drawing review and device history record review were performed as part of this investigation.The complaint is confirmed and the inability to pass the blade through the nail was replicated.No additional malfunctions were observed during investigation.The relevant drawings were reviewed during investigation.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.No definitive root cause was able to be determined.The issue is likely related to use of the incorrect aiming arm, as stated in the complaint, as well as attempting to insert the blade with the locking head element deployed in the nail.There were no issues during the manufacture of this product that would contribute to this complaint condition.The design history was not found to impact the complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.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

When the device was inspected by the manufacturer, it was noted there was damage to the helical blade.

• Brand Name: 11.0MM TI HELICAL BLADE 90MM
• 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: 6449378
• MDR Text Key: 71503434
• Report Number: 3003506883-2017-10048
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982226679
• UDI-Public: (01)10886982226679(10)H260477
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011857
• 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,Followup
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 456.303
• Device Lot Number: H260477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1