MAUDE Adverse Event Report: ZIMMER SPINE TAP DIA. 5.5 MM; INSTINCT JAVA SYSTEM

Catalog Number 046W1AN00755

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported that during the procedure the tip of the tap broke.No further surgical or patient information was provided.

Event Description

It was reported that during the procedure the tip of the tap broke.No further surgical or patient information was provided.

Manufacturer Narrative

Additional information in b4, d4 (udi), d10, device availability, g4, g7, h2, h3, h4, h6: methods, results, and conclusion codes.The specified identity of the device was confirmed and the device was examined.Visual inspection revealed the tip has fractured off.The device history record (dhr) was reviewed.There were no nonconformances or temporary deviations associated with this lot.All characteristics inspected upon initial receipt were found conforming to specifications.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.It was reported that during the procedure the tip of the tap broke.The complaint is confirmed.The exact cause of this event can't be determine with the available information.

• Brand Name: TAP DIA. 5.5 MM
• Type of Device: INSTINCT JAVA SYSTEM
• Manufacturer (Section D): ZIMMER SPINE; 23 parvis des chartrons; cite mondiale; bordeaux, cedex 33080 ; FR 33080
• MDR Report Key: 9512396
• MDR Text Key: 182792928
• Report Number: 3003853072-2019-00181
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K111301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 046W1AN00755
• Device Lot Number: A1946127A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1