MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RNGLC+ QK CONNECT ACET FLX DRL; PROSTHESIS, HIP

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 that during an initial hip arthroplasty, the drill shaft fractured while the surgeon was preparing the holes for the screws.No adverse events have been reported as a result of the malfunction and additional information on the reported event is unavailable.

Manufacturer Narrative

(b)(4) reported event was unable to be confirmed due to limited information received from the customer.Review of the device history record(s) identified no deviations or anomalies during manufacturing supplier's device history records were not reviewed as the device shows wear and tear consistent with use over a potential field age of approximately 3 years.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

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

Event Description

No additional information on the reported event.

Manufacturer Narrative

One flex drill driver was returned.Visual examination of the returned product identified nicks and scuffing on the proximal end.At rest, the shaft is bent.Multiple wires that make of the shaft have fractured but the drill remains in one piece.The additional information does not change the outcome of the previous investigation.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: 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: 12231422
• MDR Text Key: 263864809
• Report Number: 0001825034-2021-02151
• Device Sequence Number: 1
• Product Code: PBI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K121874
• 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,Followup
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• 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
• Device Lot Number: 172422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2018
• 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