MAUDE Adverse Event Report: SYNTHES MONUMENT 11MM/130 DEG TI CANN TFNA 170MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.142S

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.(b)(6).Unknown if device was bent, or broken prior to patient hearing the pop sound.(b)(4).Not explanted.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device history records review was conducted.The report indicates that the: manufacturing location: (b)(4), manufacturing date: 15-mar-2016, expiration date: 28-feb-2026, part #: 04.037.142s, lot#: h054739 (sterile) - 11mm/130 deg ti cann tfna 170mm - sterile qty.6.No 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.Sterility documentation was reviewed and determined to be conforming.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 the patient had surgery performed on (b)(6) 2016 due to a left hip fracture.Patient was implanted with a trochanteric fixation nail-advance (tfna), helical blade and one 5.0mm distal locking screw.Post- operatively while the patient was lifting a motorcycle, he reported sudden pain and a heard a pop sound.Upon examination, thru imaging of the left pelvis on (b)(6) 2016 the patient was noted to have a broken nail.Fixation nail appears to be broken at the junction were the helical blade and nail intersects.Patient is weight-bearing.Surgeon reported that the patient's bone is healing with no indication of a non-union.At this time the surgeon has no intention of removing the nail.This report is for 1 devices concomitant device reported: 5.0mm titanium distal locking screw (part # 04.005.534s, lot # h066512, qty 1), tfna helical blade 115mm sterile (part # 04.038.315s, lot # 7951411, qty 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Patient height reported as (b)(6).This complaint is for the revision surgery.During the revision the broken device and fragments were retrieved without additional intervention.The patient was implanted with new hardware (non-synthes).Device 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

On 05jan2017: update involving: part# 04.037.142s / lot#h054739 (11mm/130 deg ti cann tfna 170mm - sterile).The event description says, it was reported that the patient underwent revision surgery on (b)(6) 2017 to remove a broken trochanteric fixation nail-advance (tfna) short nail.The patient was originally implanted with the tfna short nail on (b)(6) 2016 to treat a hip fracture.During the revision the broken device and fragments were retrieved without additional intervention.The patient was implanted with new hardware (non-synthes).There was no surgical delay.No harm was reported to the patient.The patient outcome was stable and the procedure was successfully completed.This complaint is for the revision surgery.

• Brand Name: 11MM/130 DEG TI CANN TFNA 170MM - 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: 5917545
• MDR Text Key: 53585734
• Report Number: 1719045-2016-10649
• 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: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.142S
• Device Lot Number: H054739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 90