MAUDE Adverse Event Report: SYNTHES MONUMENT 12.0/8.0MM PROTECTION SLEEVE WITH FLATS; 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 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted/explanted.The subject device is not expected to be returned to the synthes manufacturer for evaluation.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture date: jul 20, 2016.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.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 while performing a suprapatellar tibial nailing procedure the surgeon had inserted the tibial nail and while attempting to drill for the proximal interlocking screws, the drill bit hit the nail.The surgeon was concerned there was an alignment issue with the synthes aiming devices.The surgeon then attempted to drill for another interlocking screw and was successful.Upon addressing the previous screw, she attempted to drill again and was successful in drilling and placing the screw.The patient also had a distal fibula fracture.While trying to place a bone clamp around the fracture, one tip of the reduction forceps broke off.The fragment was retrieved and discarded.There was a two (2) minute delay due to the reported event.The surgery was completed successfully with another clamp.The patient postsurgical outcome was reportedly fine.Concomitant devices reported: tibial nail (part #unknown, lot # unknown, quantity 1), drill bit (part #unknown lot #unknown, quantity 1).This report is 2 of 4 for (b)(4).

• Brand Name: 12.0/8.0MM PROTECTION SLEEVE WITH FLATS
• 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: 6371100
• MDR Text Key: 68774966
• Report Number: 1719045-2017-10168
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982068842
• UDI-Public: (01)10886982068842(10)H070242
• 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: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.442
• Device Lot Number: H070242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2016
• 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: UNKNOWN DRILL BIT, QUANTITY 1; UNKNOWN TIBIAL NAIL, QUANTITY 1
• Patient Age: 62 YR
• Patient Weight: 80