MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIPTIGHT AC JOINT 1 ZIPLOOP; FASTENER, FIXATION

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint cannot be confirmed since medical records or the complaint sample was not returned.Review of device history records found these units were released to distribution with no deviations or anomalies.A root cause cannot be identified with the information provided.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

It was reported that during an ac joint repair, the toggle button appeared to be seated properly, however pulled out of the patient's bone during attempted tightening.A new device was utilized to successfully complete the procedure.No additional information is available.

• Brand Name: ZIPTIGHT AC JOINT 1 ZIPLOOP
• Type of Device: FASTENER, FIXATION
• 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: 7656169
• MDR Text Key: 113009554
• Report Number: 0001825034-2018-04264
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK130033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/26/2022
• Device Model Number: N/A
• Device Catalogue Number: 904834
• Device Lot Number: 442510
• Other Device ID Number: (01) 0 0880304 47840 4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2017
• 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