MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PIN; EXTREMITY IMPLANT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/08/2023

Event Type  Injury  

Event Description

It was reported that during a primary surgery a threaded pin fractured in patient.The surgeon tried to remove the fractured device; however, device was unable to be retrieved.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

(b)(4).H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains in the patient.The investigation is in process.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

(b)(4).Reported event was unable to be confirmed.Although we have a photo of foreign body retained, it is not confirmed that this is from the pin.Radiographs were provided and reviewed however not submitted to mmi for assessment as they are intra-operative images//single timepoint and would not add value to the complaint.Also, the images appears to have been taken with a cell phone at an oblique angle which can distort the image.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.A definitive root cause could not 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.H3 other text: not returned.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No other new information.Investigation and root cause remains unchanged.

Event Description

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

• Brand Name: UNKNOWN PIN
• Type of Device: EXTREMITY IMPLANT
• 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: 17859552
• MDR Text Key: 324771340
• Report Number: 0001822565-2023-02686
• Device Sequence Number: 1
• Product Code: PHX
• 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,Followup
• Report Date: 02/19/2024
• 2 Devices were Involved in the Event: 1 2

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
• Device Catalogue Number: N/A
• Device Lot 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: 09/08/2023
• Initial Date FDA Received: 10/03/2023
• Supplement Dates Manufacturer Received: 10/10/2023; 02/15/2024
• Supplement Dates FDA Received: 11/03/2023; 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 63 YR
• Patient Sex: Male