MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH FEMORAL IMPACTOR EXTRACTOR

Model Number	6541-4-807
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Operated on a patient that had a right total knee originally on (b)(6) 2022.The reason for the operation was to retrieve a loose piece of metal that is suspected to be the tip of a femoral inserter.
Event or Problem Description
Operated on a patient that had a right total knee originally on (b)(6) 2022.The reason for the operation was to retrieve a loose piece of metal that is suspected to be the tip of a femoral inserter.
Additional Manufacturer Narrative
An event regarding crack/fracture involving a triathlon impactor was reported.The event was confirmed through visual evaluation of the provided photograph and medical review.Method & results -product evaluation and results: no product was returned for evaluation however photographs were provided.The photographs show the impactor with catalog and lot code visible.The impactor appears worn with dents and scratches consistent with in-service use.The tip of the plier has fractured off.A photograph of the fractured piece has also been provided.-clinician review: a review of medical records with a clinical consultant indicated "the x-rays show a pressfit right tka with a metallic foreign body within the lateral compartment of the knee.Incidental note is made of the presence of hardware from a previous acl reconstruction.The x-rays confirm the presence of a metallic foreign boby within the lateral compartment of a total knee.This is consistent with the event description.The root cause of this mechanical failure of the inserter cannot be determined from this limited documentation." -device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the reported lot.Conclusion: no product was returned for evaluation however photographs were provided.The photographs show the impactor with catalog and lot code visible.The impactor appears worn with dents and scratches consistent with in-service use.The tip of the plier has fractured off.A photograph of the fractured piece has also been provided.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: FEMORAL IMPACTOR EXTRACTOR
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15613334
• Report Number: 0002249697-2022-01499
• Device Sequence Number: 8073074
• Product Code: HWB
• UDI-Device Identifier: 07613327241068
• UDI-Public: 07613327241068
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2023

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: Health Professional
• Device Model Number: 6541-4-807
• Device Catalogue Number: 6541-4-807
• Device Lot Number: RD9N039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female