MAUDE Adverse Event Report: SYNTHES MONUMENT 10MM/125 DEG TI CANN TFNA 170MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.012S

Device Problem Break (1069)

Patient Problems Fall (1848); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.(b)(4).Original implant date is unknown.Device is not expected to be returned for manufacturer review/investigation.(b)(4).A device history record (dhr) review was performed.Manufacturing location: (b)(4).Manufacturing date: 31-mar-2017.Expiration date: 28-feb-2027.Part #: 04.037.012s, lot#: h355168 (sterile) - 10 mm/125 deg ti cann tfna 170 mm - sterile.Quantity 6.Component parts reviewed: part 04.037.912.2 - lock prong, 125 degree, tfna bp-55 lot - l338904.Part 04.037.912.3 - tfna lock drive bp-58 lot ¿ h335764.Part 04.037.912.4 - wave spring, shim ended bp-55 lot - h249482.Part 21127 - (b)(4) material lot bp-80 lot ¿ h201580.(b)(4) material received from supplier (b)(4) certificate of analysis received from (b)(4) for titanium meet specification.Inspection sheet for tfna assembly inspection rev: b and inspection sheet for in-process/inspect dimensional/final rev: j met inspection acceptance criteria.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.Ethicon ((b)(4)), ¿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 a patient was originally implanted three months ago for a fractured hip.The patient recently had a fall and sustained a fracture at the junction of the lag screw and broke the nail in situ.The patient had surgery (b)(6) 2017 to remove the broken nail, intact lag screw and locking screw from the left hip.The patient was revised to a long tfn.The surgery went as planned.The patient was stable following surgery.No delay or additional intervention was necessary.This complaint is for one device.Concomitant medical devices tfna screw 80 mm sterile (part 04.038.090s, lot h296266, quantity 1), 5.0 mm ti locking screw w/t25 stardrive 40 mm for im nails (part 04.005.530, lot number unknown, quantity 1).This report is 1 of 1 for com-(b)(4).

• Brand Name: 10MM/125 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: 6898433
• MDR Text Key: 87596906
• Report Number: 1719045-2017-10988
• 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
• Report Date: 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.012S
• Device Lot Number: H355168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 98