MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RNGLC+ QK CONNECT ACET FLX DRL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to location of device 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 surgeon implanted a g7 cup with correct technique during an initial tha.He was using a 40 mm drill bit with the g7 drill guide and the drill penetrated partially and encountered very hard bone.He continued to try and advance the drill and the flexible drill shaft completely broke apart.Another instrument of the same kind to finish drilling.No patient harm or injury.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: RNGLC+ QK CONNECT ACET FLX DRL
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9513397
• MDR Text Key: 195168846
• Report Number: 0001825034-2019-05732
• Device Sequence Number: 1
• Product Code: HXC
• 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
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• 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: 31-424204
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN CUP
• Patient Age: 43 YR