MAUDE Adverse Event Report: SYNTHES SELZACH INSERTION HANDLE FOR SUPRAPATELLAR; NAIL, FIXATION, BONE

Catalog Number 03.010.440

Device Problem Failure to Align (2522)

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

Event Date 09/08/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Device history records review was conducted.Dhr review for: part 03.010.440 lot 15-9957, manufacturing site: (b)(4), supplier: (b)(4), manufacturing date: 27.July 2015.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product 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 a screw missed the nail and there was difficulty removing a connecting screw during a right tibial nailing procedure on (b)(6) 2016.Approximately half way through the procedure, there seemed to be a connection problem involving the aiming arm and insertion handle.A 5.0mm dual core screw missed the nail.This caused a five minute surgical delay.Toward the end of the case, there was difficulty in removing the connecting screw.The procedure was completed successfully with the patient in stable condition.This complaint involves two devices.Concomitant devices reported: 11mm ti cannulated tibial nail (part #04.034.555s, lot #unknown, quantity 1), 5.0mm dual core screw (part #unknown, lot #unknown, quantity 1).This report is 1 of 2 for (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.

Manufacturer Narrative

Additional narrative: device was used for treatment, not diagnosis.A product development investigation was performed for the insertion handle (part number 03.010.440, lot number 15-9957).The subject device was returned with the complaint condition stating the complaint condition could not be confirmed.The returned instruments were reconstructed together in an attempt to create the complaint condition, but the complaint condition could not be recreated.Alignment of the aiming arm with the insertion handle and connecting screw was achieved when attempting to recreate the complaint condition, but during the subject procedure other variables could have contributed to the complaint condition.Since only the aiming arm, insertion handle,cannulated connecting screw were returned, it is not possible to determine if the other parts which interacted with both devices during the complaint contributed to the complaint condition.Additionally, other factors such as the patient¿s condition and physical attributes could have impacted the positioning of the instrumentation used to facilitate locking and contributed to the complaint condition.Due to the tight tolerances and design, the construct(s) is susceptible to lateral forces during the surgery that are unable to be replicated.The root cause is likely that soft tissue distractions forces are the cause of this complaint condition.All parts received were in good condition with some minor wear and tear on the devices.A device history review, a drawing review and occurrence rate review was done as a part of this investigation.Relevant drawings for the returned instruments were reviewed: the design, materials and finishing processes were found to be appropriate for the intended use of these devices.Device received on september 27, 2016.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: INSERTION HANDLE 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5981943
• MDR Text Key: 55784619
• Report Number: 3000270450-2016-10233
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111667
• 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,Followup
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.440
• Device Lot Number: 15-9957
• Other Device ID Number: 01)10886982068828(10)15-9957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/27/2015
• 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
• Treatment: 04.034.555S, 11MM TI CANNULATED TIBIAL NAIL; 5.0MM DUAL CORE SCREW (PART #UNKNOWN, LOT #UNKNOWN