MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO BIO-PREP BONE PREPARATION KIT; MIXER, CEMENT, FOR CLINICAL USE

Catalog Number	0206710000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: product not available.
Event or Problem Description
The user facility reported the plastic tool in the cement restrictor set became lodge in the femur during a procedure.After several attempts to remove, the piece broke leaving the end still attached to the restrictor.The decision made was to leave it inside in the patient.There was no medical intervention required.
Event or Problem Description
The user facility reported the plastic tool in the cement restrictor set became lodge in the femur during a procedure.After several attempts to remove, the piece broke leaving the end still attached to the restrictor.The decision made was to leave it inside in the patient.There was no medical intervention required.
Additional Manufacturer Narrative
This correction is being filed to update outcomes attributed to the adverse event.

• Brand Name: BIO-PREP BONE PREPARATION KIT
• Common Device Name: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; highway #3, km 130.2; kalamazoo MI 49001
• MDR Report Key: 8837180
• Report Number: 0001811755-2019-02588
• Device Sequence Number: 11360211
• Product Code: JDZ
• UDI-Device Identifier: 34546540039638
• UDI-Public: 34546540039638
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0206710000
• Device Lot Number: 18311012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 11/28/2020
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other