MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BICORT DEPTH GAUGE 1.3MM/1.5MM; INSTRUMENT/TRAUMA

Model Number 2312-20-124

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the instrument was fractured.Multiple attempts have been made.No response has been received at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2; h3; h6 visual examination of the returned product/provided pictures identified the item and lot numbers match the complaint.Product was not returned in its original packaging.Gauge tip looks to be bent and has resistance to pull tip in with the gauge handle.Shows signs of light wear around threads of where the tip protector threads on gauge.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.After the investigation was completed, it was determined that the event was not considered reportable.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: BICORT DEPTH GAUGE 1.3MM/1.5MM
• Type of Device: INSTRUMENT/TRAUMA
• 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: 16590538
• MDR Text Key: 312305647
• Report Number: 0001825034-2023-00616
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 00887868444784
• UDI-Public: (01)00887868444784(11)200511(10)SC20E002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2312-20-124
• Device Catalogue Number: 231220124
• Device Lot Number: SC20E002
• 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: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Male