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

Catalog Number 03.010.440

Device Problem Mechanical Jam (2983)

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

Event Date 09/09/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.A device history record review was performed for the subject device lot.Manufacturing location: (b)(4).Date of manufacture: dec 2, 2015.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 during a tibial nail procedure that the surgeon had difficulty removing the it was reported that during a tibial nail procedure that the surgeon had difficulty removing the insertion handle from the connecting screw.It took extreme force to remove the insertion handle causing an approximate five (5) minute delay to the surgery.Both devices remained intact without breakage.The surgery was completed successfully with no medical intervention necessary.The patient was stable following the surgery.This report is 2 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

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

Concomitant device reported as: unknown tibial nail (part # unknown, lot # unknown, qty 1).

Manufacturer Narrative

A product investigation was completed: a device history record (dhr) review, visual inspection, functional test, drawing review, complaint history review, and risk assessment review were performed as part of this investigation.The returned part was determined to be suitable for its intended use when employed and maintained as recommended.The connecting screw (03.010.404) was manufactured on october 26, 2015 and the insertion handle (03.010.440) was manufactured on december 02, 2015.Review of the device history records showed that there were no issues during the manufacture of these products that would contribute to this complaint condition.Per the technique guide, these devices are used together for insertion of the titanium cannulated tibial ¿ex nails when a suprapatellar approach is desired.The connecting screw and insertion handle were received intact.A dent was observed on the distal edge of the tab on the insertion handle.This is consistent with impact in the proximal direction which would be the direction of disassembly.The returned devices were functionally tested together.At no time did the devices fail to assemble/disassemble and no binding was observed.Thus, the complaint condition for the insertion handle is unconfirmed and could not be replicated.The insertion handle was determined to have not impacted the complaint condition.The distal threads and the distal shaft of the connecting screw show wear and scraping.This is indicative of the part being cross threaded and scraping against the mating device.However, the associated nail was not returned, therefore further testing with the nail in question was unable to be performed.When tested with a functional nail (part 04.034.555s, lot h161903) the connecting screw was difficult to advance and retract.Thus, the complaint condition for this device is confirmed, consistent with the reported condition, and could be replicated.A review of the current design drawing / manufactured revision for the connecting screw and the insertion handle was performed.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 their intended use when employed and maintained as recommended.The damaged on the threads of the connecting screw has resulted in the difficulty to assemble and disassemble the nail, insertion handle, and connecting screw.However, the definitive root cause which led to this occurrence could not be determined given the unknown circumstances during and prior to use.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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: 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: 5983223
• MDR Text Key: 55811012
• Report Number: 3000270450-2016-10234
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 15-5841
• Other Device ID Number: (01)10886982068828(10)15-5841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2016
• Initial Date FDA Received: 09/28/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/18/2016; 11/07/2016; 11/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2015
• 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 Age: 22 YR