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

Catalog Number	03.010.442
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6371100
• Report Number: 1719045-2017-10168
• Device Sequence Number: 16335894
• Product Code: JDS
• UDI-Device Identifier: 10886982068842
• UDI-Public: (01)10886982068842(10)H070242
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.010.442
• Device Lot Number: H070242
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2017
• Initial Report FDA Received Date: 03/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN DRILL BIT, QUANTITY 1; UNKNOWN TIBIAL NAIL, QUANTITY 1
• Patient Age: 62 YR
• Patient Weight: 80