MAUDE Adverse Event Report: SYNTHES MONUMENT 12MM/125 DEG TI CANN TFNA 400MM/LEFT - STERILE; N/A

Catalog Number 04.037.231S

Device Problem Fitting Problem (2183)

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

Event Date 11/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device has been reported as explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4).Manufacturing date: september 01, 2016.Expiration date: july 31, 2026.Sterility documentation was reviewed and determined to be conforming.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 during a trochanteric fixation nailing advanced (tfna) procedure, for a hip and proximal femoral fracture due to a patient's fall on (b)(6) 2016 as the surgeon had pre-drilled for lag screw placement into the femoral nail, it was noted that the lag screw would only insert half way thru the nail.Surgeon predrilled again with a long step drill, by hand, for a second attempt to implant the lag screw which was successful.Surgeon verified thru imaging that the preassembled locking mechanism was down and in proper position after the lag screw was in place.It was later observed by the surgeon that the lag screw was spinning inside the nail, and had a lot of play.Surgeon had chosen to leave the screw and nail in place.The proximal nail was also distally locked with two (2) locking screw implants.No time delay was reported, surgery was completed successfully and patient is reported in stable condition.Concomitant devices: distal locking screws (part unknown, lot unknown, quantity 2) this is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device has not reported as explanted.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

N/a.

• Brand Name: 12MM/125 DEG TI CANN TFNA 400MM/LEFT - STERILE
• Type of Device: N/A
• 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: 6151783
• MDR Text Key: 61785448
• Report Number: 1719045-2016-10890
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• 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,Followup
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.231S
• Device Lot Number: H178829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 2 UNKNOWN DISTAL LOCKING SCREWS
• Patient Age: 81 YR