MAUDE Adverse Event Report: SYNTHES MONUMENT TI END CAP W/T40 STRDRV 10MM EXT-STER F/TI TIBIAL NAILS-EX; NAIL, FIXATION, BONE

Catalog Number 04.004.002S

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/14/2016

Event Type  malfunction  

Manufacturer Narrative

Additional patient identifier reported as : (b)(6).(b)(4).Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.A device history record review was performed for the subject device part # 04.004.002s, lot # 9827806 (sterile) ti end cap w/t40 strdrv 10mm ext-ster f/ti tibial nails-ex: manufacturing location: supplier - mark two engineering.Packaged by: monument, manufacturing date: 24-mar-2016, expiration date: 30-nov-2024.No non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.Subject device has been received and is currently in the evaluation process.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

It was reported that during a procedure to repair a right tibial shaft fracture, while implanting a synthes 10mm titanium cannulated tibial nail, two titanium end caps would not thread onto the nail.A backup end cap was used and the procedure was completed successfully.No adverse events were reported against the patient and the patient was reported to be stable.Concomitant devices reported: 10mm titanium cannulated tibial nail, 345mm with proximal bend (part #: 04.034.449s, lot #: 7974970, qty.1).This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed.Two (2) titanium end caps, with t40 stardrive, 10mm extension, sterile, for titanium tibial nails-expert (part number 04.004.002s / lot numbers 7989142 and 9827806) were received with the complaint category of ¿device interaction: does not fit with other parts.¿ the complaint condition is confirmed as the endcaps were each received with damaged threads.The two most distal threads on lot 9827806 and all of the threads on lot 7989142 show rolled edges.Thus, the ends caps would no longer mate properly with the intended nail.Dimensional inspection of the threads could not be performed due to the post manufacturing damage.The balance of each device shows surface wear consistent with use and is in functional condition.Based on the received condition, the complaint condition is confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the threads on each device are already deformed.The returned condition is consistent with damage to the threads caused by incomplete alignment with the mating threads.The associated nail was not returned, therefore further testing with the nail in question was unable to be performed.No definitive root cause was able to be determined as circumstances surrounding the event are unknown.A device history record (dhr) review, visual inspection, drawing review, complaint history review, and risk assessment review were performed as part of this investigation.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 and the risk assessment was found to adequately address the complaint condition.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI END CAP W/T40 STRDRV 10MM EXT-STER F/TI TIBIAL NAILS-EX
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6152074
• MDR Text Key: 61724636
• Report Number: 1719045-2016-10891
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040762
• 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: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.004.002S
• Device Lot Number: 9827806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ONE (1) TIBIAL NAIL (PART #04.034.449S)
• Patient Age: 27 YR