MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TI LOW PROFILE SCREW 6.5X20MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: (46) 103531 ¿ ti low profile screw ¿ 860850; (8) 103533 ¿ ti low profile screw ¿ 860850.Report source (b)(6).Complaint sample was evaluated and the reported event was confirmed.Dimensional analysis was conducted on three pieces of each size and confirms that the item number 103533 measures as 20mm and the item number 103531 measures as 30mm.Visual inspection was conducted on the remaining returned product and found that all returned 30mm screws measured as 20mm and all returned 20mm screws measured as 30mm.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to the manufacturing process 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-01144, 0001825034-2019-01145, 0001825034-2019-01146, 0001825034-2019-01147, 0001825034-2019-01148, 0001825034-2019-01149, 0001825034-2019-01150, 0001825034-2019-01152, 0001825034-2019-01154, 0001825034-2019-01155, 0001825034-2019-01156, 0001825034-2019-01157, 0001825034-2019-01158, 0001825034-2019-01159, 0001825034-2019-01160, 0001825034-2019-01161, 0001825034-2019-01162, 0001825034-2019-01163, 0001825034-2019-01164, 0001825034-2019-01165, 0001825034-2019-01166, 0001825034-2019-01167, 0001825034-2019-01168, 0001825034-2019-01169.

Event Description

It was reported that during a knee procedure, the screws labeled as being 20mm in length actually measured as being 30mm in length and the screws labeled 30mm in length actually measured as being 20mm in length.No known adverse event was reported.Attempts have been made and additional information on the reported event is unavailable at this time.

• Brand Name: TI LOW PROFILE SCREW 6.5X20MM
• 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: 8413764
• MDR Text Key: 139322107
• Report Number: 0001825034-2019-01153
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K971890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2019

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: 103531
• Device Lot Number: 860850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 03/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1