MAUDE Adverse Event Report: SYNTHES MONUMENT 12.0/8.0MM PROTECTION SLEEVE WITH FLATS FOR SUPRAPATELLAR; NAIL,FIXATION,BONE

Catalog Number 03.010.442

Device Problem Failure to Align (2522)

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

Event Date 11/11/2016

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted / explanted.Device history records review was completed for part# 03.010.442, lot# 7660442.Supplier: (b)(6), release to warehouse date: aug 14, 2014.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product investigation was completed for part# 03.010.442, lot# 7660442.One (1)12.0/8.0mm protection sleeve with flats for suprapatellar was returned for manufacturing evaluation/investigation.A device history record (dhr) review, visual inspection, functional test, and drawing review were performed as part of this investigation.As per the technique guide, the returned devices are used together for targeted proximal locking of the titanium cannulated tibial ¿ ex nails when a suprapatellar approach is desired.The devices were each received intact.The distal threads of the connecting screw show worn edges and small indents were observed on the proximal end of the protection sleeve.The balance of each device shows wear consistent with use.When tested with a functional nail (part 04.034.555s / lot h161903) the devices were each found to function and intended and form a functional construct.The devices could subsequently be disassembled as intended.Thus, as no functional issue was identified, the complaint condition is unconfirmed and could not be replicated.A review of appropriate design drawings (current/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 parts were determined to be suitable for their intended use when employed and maintained as recommended.In conclusion, the devices were found to be in good functioning condition and did not exhibit any unspecified functional issues.The root cause could not be definitively determined as the received devices were found to function as intended.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 on (b)(6) 2016 patient underwent suprapatellar tibial nailing procedure.During the procedure while drilling to place the proximal screw, the drill bit hit the nail.The drill bit did not break.The surgeon was able to reposition the drill guide, drill the hole and place the proximal screw successfully.After the nail and screw were successfully implanted, an anticipated x-ray films were taken to confirm placement of the nail.While removing the he insertion instruments from the nail, it was noted that the insertion handle, aiming arm, connecting screw, protection sleeve and outer drill sleeves were very difficult to remove from the nail and seemed to be stuck.Surgeon had to forceably remove the instruments from the nail and caused a 15-20 minute procedural delay to remove them.The patient was stable during and following the surgery.There were no reported fragments generated and no harm to the patient was reported.Concomitant devices reported: drill guide (part # unknown, lot # unknown, quantity: 1) drill bit (part # unknown, lot # unknown, quantity: 1) this report is for one (1) protection sleeve with flats for suprapatellar.This is report 3 of 4 for (b)(4).

• Brand Name: 12.0/8.0MM PROTECTION SLEEVE WITH FLATS FOR SUPRAPATELLAR
• 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: 6149039
• MDR Text Key: 61596053
• Report Number: 1719045-2016-10885
• 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
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 03.010.442
• Device Lot Number: 7660442
• Other Device ID Number: (01)10886982068842(10)7660442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2014
• 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
• Treatment: ONE (1) UNKNOWN DRILL BIT; ONE (1) UNKNOWN DRILL GUIDE