MAUDE Adverse Event Report: SYNTHES HAGENDORF 130 DEG AIMING ARM; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 03.037.013

Device Problem Failure to Align (2522)

Patient Problem Sedation (2368)

Event Date 01/22/2016

Event Type  Injury  

Manufacturer Narrative

Device is an instrument and is not implanted or explanted.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history record review: manufacturing location: (b)(4) - manufacturing date: july 14, 2015.No non-conformance reports were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.Device 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 the helical blade missed the nail as it was being inserted through the insertion handle and aiming arm during a trochanteric fixation nail advanced (tfna) procedure to treat a subtrochanteric fracture.It was discovered later in the procedure that the helical blade was outside the nail.Both the blade and the nail were removed; the nail was able to be re-used.The helical blade was exchange with another for size, not due to any reported damage.The instruments worked fine on the second attempt; however, the issue itself appeared to reside with the insertion handle and aiming arm, not the helical blade or nail.The procedure was completed with a twenty (20) to thirty (30) minute delay.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the aiming arm does not show any significant wear.There is no damage that would indicate a loss in function.All markings are clear and legible.The returned instrument was tested with the other instruments associated with aiming and functioned properly.When assembled they were able to properly target the oblique hole of the nail, a guide wire inserted through the wire guide sleeve passed through the oblique hole as intended.Therefore this complaint event cannot be replicated and is unconfirmed, and it is most likely caused by misuse.Possible causes are soft tissue forces pressing on the aiming instrumentation, or loosening of the connecting screw without any post-insertion tightening.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.No manufacturing or design issues were noted during the investigation.The design is determined to be adequate for its intended use when used and maintained as recommended.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.

• Brand Name: 130 DEG AIMING ARM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5434957
• MDR Text Key: 38205245
• Report Number: 3003875359-2016-10101
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK131548
• 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: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.037.013
• Device Lot Number: 9474935
• Other Device ID Number: (01)10886982070296(10)9474935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention