MAUDE Adverse Event Report: SYNTHES MONUMENT 9MM TI CANNULATED TIBIAL NAIL-EX/330MM-STERILE; NAIL, FIXATION, BONE

Catalog Number 04.004.346S

Device Problem Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 09/09/2016

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.(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.: the subject device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.(b)(6).(b)(4) was utilized because surgeon had to remove the nail and insert another nail through the patellar tendon approach using regular instrumentation.A device history record review was performed for the complaint device lot.Manufacturing location: (b)(4).Date of manufacture: feb 18, 2015.Expiration date: jan 31, 2024.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 complaint device.The sterility documentation for this lot was also reviewed and was found to be conforming.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

(b)(6) reported the following event: it was reported that during an intramedullary nailing of the tibia using the suprapatellar instrumentation, the percutaneous connecting screw became jammed into nail.It was impossible to take the percutaneous handle and nail apart.The surgeon was forced to remove the nail and insert another nail through the patellar tendon approach using regular instrumentation.The surgery was delayed 30 minutes due to the reported event.All devices remained intact.This report is 2 of 3 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

An investigation summary was performed.The investigation of the complaint articles has shown that: 11/4/2016 the subject device was received by the synthes manufacturer on oct 3, 2016 attached to another device.Upon receipt, it was not known that this device had been received because it was attached to the other device.It was not known these devices were actually two separate devices returned assembled together.Upon inspection of the received devices by synthes customer quality engineering on nov 2, 2016, the devices were inspected and then detached.It was then discovered that the subject device had actually been received and is a separate device 09nov2016: lot number, dhr, manufacturing site, manufacturing date updated.The complaint condition for the insertion handle is unconfirmed as no binding was observed with the connecting screw.A device history record (dhr) review, visual inspection, functional test, and drawing review were performed as part of this investigation.The insertion handle was determined to function as intended and to have not contributed to the complaint condition.Thus, no further investigation on this device (including a risk assessment review) is warranted.The complaint condition is confirmed for the connecting screw and the nail as functional testing revealed that wear on the threads and shaft of the connecting screw and the inner proximal diameter and threads of the nail has resulted in difficulty to disassembly the devices.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 parts were determined to be suitable for their intended use when employed and maintained as recommended.The risk assessment was found to adequately address the occurrence for the nail but not for the connecting screw.The nail, connecting screw, and insertion handle were received intact and stuck together.Significant force was required to separate the connecting screw from the nail.Once the connecting screw was unthreaded from the nail the insertion handle could be easily removed.The returned connecting screw and insertion handle 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.When the connecting screw was functionally tested with the returned nail the devices did bind and were difficult to disassemble.The distal threads and shaft of the connecting screw and the inner proximal diameter and threads of the nail show wear and scraping.This is indicative of extensive force and the part being cross threaded and scraping against the mating device.Thus, the complaint condition for the connecting screw and nail is confirmed, consistent with the reported condition, and could be replicated.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.

• Brand Name: 9MM TI CANNULATED TIBIAL NAIL-EX/330MM-STERILE
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5956276
• MDR Text Key: 54923620
• Report Number: 1719045-2016-10688
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 04.004.346S
• Device Lot Number: 7921506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2016
• Initial Date FDA Received: 09/16/2016
• Supplement Dates Manufacturer Received: 11/11/2016; 11/11/2016
• Supplement Dates FDA Received: 10/21/2016; 11/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention