MAUDE Adverse Event Report: SYNTHES SELZACH AIMING ARM FOR SUPRAPATELLAR; NAIL, FIXATION, BONE

Catalog Number 03.010.441

Device Problem Failure to Align (2522)

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

Event Date 10/06/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information was not provided by reporter.Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation.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.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 Description

It was reported that the tibia nail ex aiming guide missed the targeted hole in the nail multiple times.There was a 15 minute delay to the surgery.The surgery was successfully completed.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device.One aiming arm for suprapatellar (part number 03.010.441, lot number 14-1990) was received with the complaint that a tibia nail ex aiming guide missed the targeted hole in the nail multiple times.There was a 15 minute delay to surgery.Surgery was successfully completed.This device is used for targeted proximal locking of the titanium cannulated tibial ¿ex nails when a suprapatellar approach is desired.Information is provided per the suprapatellar instrumentation technique guide.A review of the current design drawing / manufactured revision was performed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.The returned aiming arm was received intact and with no noted damage or wear.The device was tested functionally with known good in-house parts.The following were used for testing; a titanium cannulated tibial nail- ex (part number 04.034.343, lot number 6399565), an insertion handle, for suprapatellar (part number 03.010.440, lot number 10-6493), a cannulated connecting screw (part number 03.010.404, lot number u125688), a protection sleeve (part number 03.010.442, lot number 6531049-i), a drill sleeve (part number 03.010.064, lot number 1496453), and a 3.2mm drill bit (part number 03.010.060, lot number 057113).The construct was assembled and all of the targeted locking locations were tested and at no time did the construct fail to properly align.Thus, the complaint condition is unconfirmed, inconsistent with the reported condition, and could not be replicated.The received, fully functional condition of the aiming arm suggests that the most probable cause of the complaint condition was related to the user technique.It is likely incomplete tightening of the assembly or forces placed on the construct during surgery resulted to this unconfirmed complaint.However, as these circumstances are unknown the root cause cannot be definitively determined.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: AIMING ARM FOR SUPRAPATELLAR
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5161487
• MDR Text Key: 28719662
• Report Number: 3000270450-2015-10213
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.441
• Device Lot Number: 14-1990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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