MAUDE Adverse Event Report: SYNTHES ELMIRA 11.0MM TI HELICAL BLADE 105MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 456.306S

Device Problems Component Missing (2306); Packaging Problem (3007)

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

Event Date 07/14/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient initials are (b)(6).Patient information was not available for reporting.Additional device product code is hwc.(b)(4).As reported, the device was missing from its packaging and was not able to be implanted.The complaint device is not expected to be returned to the synthes manufacturer for evaluation.Evaluation of the product itself is not relevant to the complaint issue.As reported, only the empty sterile packaging was found.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.This order met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Product manufacture date: january 12, 2016.Part expiry date: november 30, 2024.The investigation could not be completed; no conclusion could be drawn.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 during an open reduction internal fixation procedure to treat a hip fracture, it was discovered that the helical blade was missing from its sterile packaging.The empty helical blade package was included in the trochanteric fixation nail system tray.An additional device was not readily available to complete the procedure and there was a 50 minute surgical delay due to the time it took to get another sterile helical blade.The procedure was completed and the patient's condition was reportedly stable.This report is 1 of 1 for (b)(4).

• Brand Name: 11.0MM TI HELICAL BLADE 105MM-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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5841787
• MDR Text Key: 51001635
• Report Number: 3003506883-2016-10130
• Device Sequence Number: 1
• Product Code: HSB
• 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
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 456.306S
• Device Lot Number: 9976415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1