MAUDE Adverse Event Report: SYNTHES MONUMENT 11MM/130 DEG TI CANN TFNA 420MM/RIGHT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.162S

Device Problem Bent (1059)

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

Event Date 08/24/2017

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: (b)(6).(b)(4).Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.Complainant device is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was performed for part #: 04.037.162s, lot#: h210781 (sterile) - 11mm/130 deg ti cann tfna 420mm / right - sterile.Quantity 5, manufacturing location: (b)(4) , manufacturing date: 18-oct-2016, expiration date: 30-sep-2026.Component parts reviewed: part 04.037.942.2 - lock prong, 130 degree, tfna bp-55 lot ¿ 9907525, part 04.037.912.4 - wave spring, shim ended bp-55 lot - h089447, part 04.037.912.3 - tfna lock drive bp-58 lot - h178971, part 21127 - raw material lot bp-80 lot ¿ h205560.Raw material received from supplier (b)(4).Certificate of test received for titanium from (b)(4) meet specification.Raw material receiving/putaway checklist meet requirements.Inspection sheet for tfna assembly inspection and inspection sheet for in-process/inspect dimensional/final met inspection acceptance criteria.No non-conformance reports (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.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 surgery on (b)(6) 2017, a surgeon was putting in a lag screw in a tfn-a (trochanteric fixation nail-advanced), and proceeded to tighten down the preassembled locking mechanism (set screw).He then decided to advance the lag screw another full rotation.He unlocked the set screw and advanced the lag screw, and when he went to retighten the set screw, he realized it would not lock the rotation of the lag screw.The tfn-a nail was taken out of the patient and the set screw was removed from the nail.It was then noticed that the locking mechanism (set screw) had become slightly bent.Another nail was opened and the surgeon completed the case with no further problem.There was a ten (10) minute surgical delay to obtain and insert another nail.There was no reported harm to the patient, and patient's outcome was good.Concomitant device: unknown lag screw for tfn-a nail (part # unknown, lot # unknown, qty.1).This report is for one (1) 11mm/130 degree ti cannulated tfna.(b)(4).

• Brand Name: 11MM/130 DEG TI CANN TFNA 420MM/RIGHT - 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: 6869490
• MDR Text Key: 86416075
• Report Number: 1719045-2017-10920
• 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: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.162S
• Device Lot Number: H210781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 61