MAUDE Adverse Event Report: SYNTHES MONUMENT 11.0MM TI TROCH FIXATION NAIL SCREW/110MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.032.110S

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Date of device ¿cut out¿ is not known.Additional product code: hwc.(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review.Part number: 04.032.110s, synthes lot number: 9843082, supplier lot number: n/a, release to warehouse date: 10-jul-2015, expiration date: 31-may-2025, manufactured by synthes (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this 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.

Event Description

It was reported that a patient had to undergo revision of a trochanteric fixation nail (tfn) short nail due to cut-out of the lag screw on (b)(6) 2017.The patient had originally undergone surgery on (b)(6) 2017 and was implanted with the short nail, a lag screw, and a 5 mm locking screw.However, at a later date postoperatively (exact date unknown) it was discovered through an x-ray that the lag screw had cut out.The x-ray showed that five (5) mm of the lag screw were outside of the femoral head.It was concluded revision surgery was needed.The revision surgery took place on (b)(6) 2017.The patient was revised to a stryker total hip.The surgery was successfully completed with no delay.The patient outcome was reported as fine.Concomitant devices reported: 5.0 mm locking screw (part 04.005.534, lot number 9815462, quantity 1), 11 mm 130 degree cannulated tfn nail 170 mm (short nail) (part 456.318, lot number h150562, quantity 1).This report is for one (1) 11.0 mm tfn screw 110 mm.This is report 1 of 1 for (b)(4).

• Brand Name: 11.0MM TI TROCH FIXATION NAIL SCREW/110MM - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• 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: 6926910
• MDR Text Key: 88938124
• Report Number: 1719045-2017-11031
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092646
• 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: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.032.110S
• Device Lot Number: 9843082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 97