MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 1.7 MM SQUARE DRIVER; DRIVER, PROSTHESIS

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 11/02/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: foreign country: (b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified the device is fractured.Device was submitted for further analysis.Analysis determined that the device fractured due to torsional overload.The crack initiation is suspected to be at one of the four corners of the square driver.Sheared ductile overload dimples identified in multiple regions on the fracture surface.The final rupture appeared to be in the center of the fracture in tensile overload mode, exhibiting normal ductile dimples.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported the screwdriver socket does not fit into screw head.It was reported attachment is too big and missing gradation.The product was returned fractured.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: 1.7 MM SQUARE DRIVER
• Type of Device: DRIVER, PROSTHESIS
• 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: 13693122
• MDR Text Key: 287276490
• Report Number: 0001825034-2022-00477
• Device Sequence Number: 1
• Product Code: HWR
• UDI-Device Identifier: 00880304533516
• UDI-Public: (01)00880304533516(11)210109(10)CA5JL57
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 231200101
• Device Lot Number: CA5JL57
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2021
• 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