MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPRESS SMALL SPINDLE WITH PINS 800LBF; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/14/2023

Event Type  Injury  

Event Description

It was reported that during knee arthroplasty upon insertion of the spindle, the drill for pin insertion fractured and was retained in the bone while drilling through the guide.Another drill was used to complete the procedure; however, the fractured end of the drill remained in the patient's bone.There are currently no plans to remove the fractured piece.Attempts have been made; however, no additional information is available.

Manufacturer Narrative

(b)(4).G2 - report source - foreign: the event occurred in japan.The complainant has indicated that the fractured drill is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

Visual examination of the returned product identified the tip of the drill was fractured.The device and packaging were submitted for further analysis.Fracture analysis determined the fracture was related to torsional overload and material analysis confirmed the device was consistent to print specification, indicating no manufacturing issues.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: COMPRESS SMALL SPINDLE WITH PINS 800LBF
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17276859
• MDR Text Key: 318550864
• Report Number: 0001825034-2023-01498
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 178355
• Device Lot Number: 862070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 65 KG