MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECON KNOB T2 ALPHA FEMUR ANTEGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2353-3301
Medical Device Problem Codes	Failure to Align (2522); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "when setting nail depth version with drill tip icon wires we backed the wires.Of femoral neck all need, moved nail/ targeter more anterior on patient to aim more posterior for optimal version.The wire then missed the nail anterior to the nail.Caused a delay in the case to execute correct rotation of nail." length of the delay was not provided.
Event or Problem Description
As reported: "when setting nail depth version with drill tip icon wires we backed the wires.Of femoral neck all need, moved nail/ targeter more anterior on patient to aim more posterior for optimal version.The wire then missed the nail anterior to the nail.Caused a delay in the case to execute correct rotation of nail." length of the delay was not provided.
Additional Manufacturer Narrative
Correction: please refer to h6 device code, h6 clinical & health code.This device is concomitant and did not contribute to the reported failure.Since function had been confirmed for all returned product[s] the knob was classified as concomitant product ¿ it had not contributed to alleged mis guiding.Therefore, this complaint is closed without further investigation.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

• Brand Name: RECON KNOB T2 ALPHA FEMUR ANTEGRADE
• Common Device Name: 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13361348
• Report Number: 0009610622-2022-00033
• Device Sequence Number: 16582333
• Product Code: HSB
• UDI-Device Identifier: 07613327338638
• UDI-Public: 07613327338638
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2353-3301
• Device Catalogue Number: 23533301
• Device Lot Number: KP423291
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2021
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Sex: Unknown