MAUDE Adverse Event Report: SYNTHES MONUMENT 10MM/130 DEG TI CANN TFNA 200MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.043S

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reporter address, phone number is not provided for reporting.A device history record (dhr) review was performed for part #: 04.037.043s, lot#: h035280 (sterile) - 10 mm/130 deg ti cann tfna 200 mm - sterile.Quantity 6: manufacturing location: (b)(4), manufacturing date: 19-feb-2016, expiration date: 28-feb-2026: component parts reviewed: part 04.037.942.2 - lock prong, 130 degree, tfna bp-55 lot ¿ 9769895, part 04.037.912.4 - wave spring, shim ended bp-55 lot ¿ 7921068, part 04.037.912.3 - tfna lock drive bp-58 lot ¿ 9972044: part 21127 - raw material lot bp-80 lot - 9947470.Raw material received from supplier (b)(4).Certified test report received from (b)(4) for titanium and certificate of analysis received from (b)(4).Meet specification.Raw material receiving/putaway checklist meet requirements.Inspection sheet for in-process/inspect dimensional/final ns063029 rev: e and inspection sheet for tfna assembly inspection 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 device has been received and the product evaluation is in progress.No conclusion can be drawn.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

Device report from synthes europe reports an event in (b)(6) as follows: it was reported a patient was implanted with a tfn-advanced proximal femoral nailing system (tfna) short nail for the femoral trochanteric fracture on (b)(6) 2017.During the follow-up visit on (b)(6) 2017, it was found that the femoral head became a varus position, and the nail was almost cut out.When the patient came back again for pain on (b)(6) 2017, it was found that the nail in question was broken and cut out.The removal surgery of the nail and bha were performed on (b)(6) 2017.The surgeon commented that the reduction might not have been sufficient during the primary surgery in june.Concomitant parts reported: 5.0 mm ti locking screw (part # 04.005.532s, lot # l301269, quantity 1), tfna helical blade 115 mm sterile (part # 04.038.315s , lot # 7712691, quantity 1).This report is for one (1) 10 mm/130 deg ti cann tfna 200 mm - sterile.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A manufacturing investigation was performed for the subject device (tfna fem nail ø10 130° l200 timo15, part number 04.037.043s, lot number h035280).The subject device was returned to the manufacturer with the complaint condition stating: nail broke from the hole into two pieces and there is a small broken.The length of the nail was measured with a calibrated scale (calibration id #(b)(4)) and measured 200mm, which meets the specification of the top-level drawing.The diameter of the nail was measured with gto65232 (calibration id #(b)(4)) and measured 10mm, which meets the specification of the top-level drawing.The nail was unevenly broken at the oblique hole, as well as having the lock prong, lock drive and guide spring components installed in the head of the nail; therefore, the lateral bend angle cannot be measured, nor other dimensions associated with the nail at the place of the break.The available data supports the complainant¿s description of the complaint condition of "nail broken" therefore this complaint is confirmed.The surgeon commented that the reduction might not have been sufficient during the primary surgery in june and may that could break the nail.However, we cannot confirm that how the nail was broke, so the cause is undetermined.No manufacturing related issue was identified and/or confirmed.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.

• Brand Name: 10MM/130 DEG TI CANN TFNA 200MM - 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: 6946233
• MDR Text Key: 89285011
• Report Number: 1719045-2017-11053
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.043S
• Device Lot Number: H035280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/12/2017
• Supplement Dates Manufacturer Received: 11/08/2017
• Supplement Dates FDA Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 86