MAUDE Adverse Event Report: STRYKER GMBH ARTHRODESIS NAIL, RIGHT T2 KNEE ARTHRODESIS Ø11.5 X 740MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18291174S

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Non-union Bone Fracture (2369)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.

Event Description

Patient called stating she had a t2 nail implanted in her right knee in (b)(6) 2017.In (b)(6) 2018, a screw was removed from the nail and bone cement applied due to non-union.

Event Description

Patient called stating she had a t2 nail implanted in her right knee in (b)(6) of 2017.In (b)(6) of 2018, a screw was removed from the nail and bone cement applied due to non-union.

Manufacturer Narrative

Correction - please refer to d1 product long description, d2a, d2b, d3, g1 reporting contact.The anatomical location of the described event narrows down the applicable device to a t2 femur nail.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.If the device is returned or if any additional information is provided, the investigation will be reassessed.Update april 2024: the patient contacted stryker in 2024 to request the material composition of the implants (t2 nail as well as the cement used during her procedure).The material composition of catalog number 18291174 (arthrodesis nail, right t2 knee arthrodesis 011.5 x 740mm) was provided.This device is made of titanium (ti6 al 4v eli) that includes the following elements : chemical composition (mass ): carbon (c) - 0.08, aluminum (ai) - 5.5 ¿ 6.5, vanadium (v) 3.5 ¿ 4.5, iron (fe) - 0.25, oxygen (o) - 0.13 , nitrogen (n) - 0.05, hydrogen (h) - 0.012a , titanium (ti) ¿ balance.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: ARTHRODESIS NAIL, RIGHT T2 KNEE ARTHRODESIS Ø11.5 X 740MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8861470
• MDR Text Key: 153380979
• Report Number: 0009610622-2019-00603
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 18291174S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 08/05/2019
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 61 YR
• Patient Sex: Female