MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIPTIGHT ANKLE SYN FIXATION-TI ION TI; SPORTSMED, IMPLANTS

Model Number N/A

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: item# 110005307; lot# 575900; jgrknt short rigid sz1 imp/drl.Foreign: event occurred in (b)(6).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: 0001825034-2020-04448.

Event Description

It was reported that during inspection, the piece was found open.Not patient involved.No surgery occurred.

Event Description

Upon visual evaluation, it has been determined that the sterile packaging remained intact and unopened.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon visual evaluation, it has been determined that the sterile packaging remained intact and unopened.The initial report was forwarded in error and should be voided.

• Brand Name: ZIPTIGHT ANKLE SYN FIXATION-TI ION TI
• Type of Device: SPORTSMED, IMPLANTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11154617
• MDR Text Key: 226261710
• Report Number: 0001825034-2020-04449
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 0088030476103
• UDI-Public: (01)0088030476103
• Combination Product (y/n): N
• PMA/PMN Number: K083070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 904759
• Device Lot Number: 068640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1