MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PIN; INSTRUMENT, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/11/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: associated product: patella reamer blade with pilot hole 51 mm diameter.Item# 00597909551,lot# 64981757.Headless trocar drill pin 3.2 mm diameter 75 mm length.Item# 00590102000, lot# 64957228.Femur cemented posterior stabilized (ps) standard left size 11.Item# 42500607001, lot# 64792935.Tibia cemented 5 degree stemmed left size f, item# 42532007501, lot# 64852231.All poly patella cemented 41 mm diameter item# 42540000041 lot# 64890080 articular surface fixed bearing posterior stabilized (ps) left 10 mm height.Item# 42511400810, lot# 64884335.Cas fixation pin 3.2d x 150mm sterile, item# 20800000010, lot# 64954872.Customer 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.

Event Description

It was reported that when explanting two pins from the distal femur the tip of one of the pins broke off in the femur.Attempts to obtain additional information have been made; however, no more information is available at this time.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Medical records were not provided device history record (dhr) review was unable to be performed as the part and lot number of the device involved in the event is unknown.A definitive root cause cannot be determined.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 PIN
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12348449
• MDR Text Key: 267500646
• Report Number: 0001822565-2021-02323
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

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: 05/20/2021
• Initial Date FDA Received: 08/20/2021
• Supplement Dates Manufacturer Received: 11/02/2021
• Supplement Dates FDA Received: 11/10/2021
• 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: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other
• Patient Sex: Male