MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PERSONA 4 IN 1 CUT GUIDE; INSTRUMENT, KNEE

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem Laceration(s) (1946)

Event Date 06/13/2022

Event Type  malfunction  

Event Description

It was reported that during knee arthroplasty when the surgeon was drilling the hex headed screw through the 4-in-1 cutting block, metal shavings milled off the screw and formed a sharp edge that subsequently cut the surgeon.The surgeon suffered heavy bleeding to his finger, increasing his risk of infection.There was no reported impact to the patient, however, the surgery was delayed fifteen (15) minutes due to the surgeon's injury.Attempts have been made, however, no additional information is available.

Manufacturer Narrative

(b)(4).Concomitant medical devices: persona revision hex headed screw 3.5mm hex 48mm length, catalog #: 00590103548, lot #: ni.Report source - foreign: switzerland.The complainant has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this patient; please see all reports associated with this event: 0001822565-2022-01995.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections have been corrected/updated: b1; b4; b5; g3; h1; h2; h6; h10.Upon review of additional information, this event was determined to be not reportable.A serious adverse event did not occur as a result of the reported device malfunction.Though the healthcare professional sustained injury, the injury was minor in nature and did not require medical intervention to resolve.The previous reports regarding this event were submitted in error and should be voided.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.

Event Description

Upon review of additional information, this event was determined to be not reportable.A serious adverse event did not occur as a result of the reported device malfunction.Though the healthcare professional sustained injury, the injury was minor in nature and did not require medical intervention to resolve.The previous reports regarding this event were submitted in error and should be voided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device history records could not be reviewed as the lot number associated with the reported event is unknown.Based on the information provided, the injury to the user was caused due to the pin stripping, however, 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.

Event Description

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

• Brand Name: UNKNOWN PERSONA 4 IN 1 CUT GUIDE
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15581988
• MDR Text Key: 301548463
• Report Number: 0001822565-2022-02947
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: NI
• 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,Followup
• Report Date: 12/13/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 10/18/2022; 11/22/2022
• Supplement Dates FDA Received: 10/25/2022; 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose