MAUDE Adverse Event Report: SYNTHES MONUMENT 12.0MM PROTECTION SLV STRAIGHTFOR 8MM-11MM NAILS; NAIL, FIXATION, BONE

Catalog Number 03.010.435

Device Problem Mechanical Jam (2983)

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

Event Date 03/06/2017

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A device history record (dhr) review was performed on part # 03.010.435, lot # 9885808: release to warehouse date: 15 dec 2015, expiration date: na, supplier: (b)(4).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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient underwent surgery for a tibia fracture (side unknown) on (b)(6) 2017.During the procedure while the surgeon was treating the patient with a suprapatellar tibia nail and upon exchange of the 12mm protection sleeve; the sleeve would not release from the suprapatellar handle effectively.The surgeon eventually was able to release the sleeve from the handle by manually pulling the sleeve from the handle with a pair of pliers.The surgeon was unsure as to which device was defective or possibly both.There was a surgical time delay of approximately twenty to thirty (20-30) seconds.There was no additional medical or surgical intervention and no x-rays.The surgery was successfully completed.There was no harm to the patient and the patient status outcome is fine.Concomitant medical products: suprapatellar titanium cannulated tibia nail (part # unknown, lot # unknown, quantity 1).This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

A product investigation was completed: the 03.010.430 lot number t129418 handle for protection sleeves was returned and reported to not release from the 03.010.435 12.0 mm protection sleeve properly.This complaint condition was likely caused by intraoperative conditions preventing the full depression of the release mechanism and proper detachment; however, this complaint is not likely a result of any design or manufacturing related deficiency.A visual inspection, device history record review, and drawing review were performed as part of this investigation.This complaint is confirmed.Per the technique guide, the 03.010.430 handle for protection sleeves is an instrument routinely used in suprapatellar instrumentation for titanium cannulated tibial nails system.The device was returned and reported to not release from the protection sleeve properly.This condition is confirmed; while the protection sleeve was not returned to test, the lip and proximal portion of the handle show scrape marks and deformation consistent with forcible removal of the protection sleeve.It is likely that intraoperative conditions preventing the full depression of the release mechanism and proper detachment has led to this complaint condition.The device was manufactured in february 2016 and is over a year old.The balance of the returned device is in otherwise fairly good condition without much superficial wear.The relevant drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned device does agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.Upon review of the device history record, no non-conformance reports germane to the complaint condition were generated during the production of this device.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: 12.0MM PROTECTION SLV STRAIGHTFOR 8MM-11MM NAILS
• 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: 6437154
• MDR Text Key: 70991733
• Report Number: 1719045-2017-10261
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982068767
• UDI-Public: (01)10886982068767(10)9885808
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.435
• Device Lot Number: 9885808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2015
• 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: TIBIA NAIL (PART # UNKNOWN, LOT # UNKNOWN, QTY 1)
• Patient Age: 56 YR