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

Catalog Number	18291174S
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Nonunion/Delayed-union Bone Fracture (2369); Ambulation or Postural Difficulties (2544)
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device remains implanted.
Event or Problem Description
It was reported that patient's right knee was revised in (b)(6) 2018 with the removal of a screw from a t2 nail.In (b)(6) 2019, surgeon pronounced patient as 70% healed (range-of-motion issues) and nothing further could be done.Patient continues to need crutches to ambulate.
Additional Manufacturer Narrative
The anatomical location of the described event narrows down the applicable device to a t2 femur nail.The reported event that t2 nail was alleged of non-union 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.
Event or Problem Description
It was reported that patient's right knee was revised in (b)(6) 2018 with the removal of a screw from a t2 nail.In (b)(6) 2019, surgeon pronounced patient as 70% healed (range-of-motion issues) and nothing further could be done.Patient continues to need crutches to ambulate.

• Brand Name: ARTHRODESIS NAIL, RIGHT T2 KNEE ARTHRODESIS Ø11.5 X 740MM
• Common Device Name: 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: 8867746
• Report Number: 0009610622-2019-00605
• Device Sequence Number: 16967770
• Product Code: HSB
• UDI-Device Identifier: 07613153297482
• UDI-Public: 07613153297482
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K020384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 18291174S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 62 YR
• Patient Sex: Female