MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CALIBRATED DRILL 4.3MM; BIT, DRILL

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported during the inspection of the kit in the (b)(6) warehouse, it has been detected that the piece has a broken tip.No patient involvement.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.No product was returned; visual and dimensional evaluations could not be performed.A box with paperwork in it without the complaint product was returned.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 cannot 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Customer indicated the product was returned to zimmer biomet for investigation; however, this shipment arrived without the device in the package.The location of the device is unknown.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.

• Brand Name: CALIBRATED DRILL 4.3MM
• Type of Device: BIT, DRILL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10185885
• MDR Text Key: 198717870
• Report Number: 0001825034-2020-02470
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 00880304490420
• UDI-Public: (01)00880304490420
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2020

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: 41010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 06/23/2020
• Supplement Dates Manufacturer Received: 10/07/2020; 10/07/2020
• Supplement Dates FDA Received: 10/07/2020; 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1