MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ARTICULAR SURFACE INSERTER TIP DO NOT IMPLANT; INSTRUMENT, KNEE

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign - (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 when the surgeon opened the package of the ppk inserter tip, he found that something like lint was seen on the product.Subsequently, he decided not use it and another ppk inserter tip was used to complete the procedure.

Event Description

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

Manufacturer Narrative

Visual inspection of returned packaging and product found the carton and cavities were opened.Evaluation of the product and packaging did not find any foreign debris.The dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined as the product and packaging were returned opened, and therefore it cannot be determined when or how the foreign debris was introduced.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.

• Brand Name: ARTICULAR SURFACE INSERTER TIP DO NOT IMPLANT
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11506965
• MDR Text Key: 246846781
• Report Number: 0001822565-2021-00748
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00880304810211
• UDI-Public: (01)00880304810211(17)250331(10)64655909
• 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: 04/21/2021

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: 42529900301
• Device Lot Number: 64655909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 04/21/2021
• Supplement Dates FDA Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1