MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 4-IN-1 ANTERIOR REFERENCING CUT GUIDE SIZE 6; INSTRUMENT, KNEE

Model Number N/A

Device Problems Device Damaged by Another Device (2915); Mechanical Jam (2983)

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

Event Date 05/26/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source - (b)(6).The 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-01799.

Event Description

It was reported that during an initial knee arthroplasty, the surgeon was unable to remove one of the pins because it was stuck in the cut guide.The surgeon was still able to remove the cut guide from the bone.Outside the sterile field, the drill pin was removed from the cut guide using a vice-grip.However, the hole was damaged because when it was tested, the pin would not go into the hole smoothly.There was no consequences or impact to the patient.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Visual examination of the returned product [item#: 42538100401] identified signs of use (nicked/gouged).Dimensional analysis of the product found that the a drill pin hole was non-conforming to print specifications as burrs and striations are visible around inside edges of the hole from wear and over 4 years of use.The device history record was reviewed and no discrepancies relevant to the reported event were found.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.

Event Description

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

• Brand Name: 4-IN-1 ANTERIOR REFERENCING CUT GUIDE SIZE 6
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14688748
• MDR Text Key: 294058213
• Report Number: 0001822565-2022-01798
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00889024232778
• UDI-Public: (01)00889024232778(10)64044465
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K113369
• 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: 09/23/2022

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: 42509908560
• Device Lot Number: 64044465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 06/14/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2018
• 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