MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MODULAR FLEX DRILL BIT 3.2 MM DIAMETER 30 MM LENGTH; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/28/2022

Event Type  Injury  

Event Description

It was reported the drill broke during drilling when fixing the acetabular shell.Fragment of this drill remained inside the acetabular bone.The surgeon commented that patient is under observation.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, product was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device was discarded.

Event Description

No additional information on the reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6 component code: mechanical - g (04) drill.No product was returned; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records and was not provided.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.

• Brand Name: MODULAR FLEX DRILL BIT 3.2 MM DIAMETER 30 MM LENGTH
• Type of Device: PROSTHESIS, HIP
• 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: 14394584
• MDR Text Key: 291605678
• Report Number: 0001822565-2022-01399
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• 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: 00879000703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2022
• 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: NI
• Patient Sequence Number: 1
• Patient Outcome(s): Other