MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R2.0, TI, LEFT T2 RECON Ø9X340 MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 1846-0934S

Device Problems Break (1069); Fracture (1260)

Patient Problems Fall (1848); Failure of Implant (1924)

Event Date 05/18/2021

Event Type  Injury  

Manufacturer Narrative

Upon completion of the investigation any additional information will be communicated in a supplemental report.

Event Description

It was reported that following a fall, a patient had her t2 reconstruction nail (t2g nail, d9, l340, (b)(4), lot k055b06ra) explanted, which was broken.The nail was installed on (b)(6) 2021.

Event Description

It was reported that following a fall, a patient had her t2 reconstruction nail (t2g nail, d9, l340, ref 1846-0934s, lot k055b06ra) explanted, which was broken.The nail was installed on (b)(6) 2021.Update - (b)(6) 2021: removal of the nail under ga and insertion of a specific prosthesis for complex fracture of the trochanteric mass.

Manufacturer Narrative

Please note correction to section d4 lot number and h6 (device and health impact codes).The reported event could be confirmed, since the nail is broken as complained.The device inspection revealed the following: the visual inspection has shown that the is broken apart at the lower proximal lag screw hole.At both proximal lag screw holes are strong grooves from an excessive contact with the reamer during insertion visible.A microscopic inspection of the fracture face on the head piece was made.The typical characteristics of a fatigue fracture could be identified on both fracture faces.The origin of the crack was at the lower corners, the crack started at the right side of the hole at the with the reamer caused damage the above described groove and did later continue at the left side of the hole.There is a fatigue zone with progression lines.The instantaneous zone where the nail finally, most likely during the in the event description mentioned fall, broke apart is visible too.On top of the bore is an impression mark visible, caused by high loads between the nail and the lag screw.The relevant dimensions were as far as possible checked and no deviation from the specification could be detected.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a patient related issue.Based on the investigation findings did high loads over time lead to a fatigue failure of the nail.In this relation following statement from the instructions for use (non-active implant) can be pointed out: [these devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.]¿ [original statement] if more information is provided, the case will be reassessed.

• Brand Name: RECONSTRUCTION NAIL R2.0, TI, LEFT T2 RECON Ø9X340 MM X 125°
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12652219
• MDR Text Key: 277099793
• Report Number: 0009610622-2021-00763
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613153318712
• UDI-Public: 07613153318712
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K032898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2021
• Device Model Number: 1846-0934S
• Device Catalogue Number: 18460934S
• Device Lot Number: K055B06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 62 KG