MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. TELLURIDE TAP CANNULATED 4.5MM

Catalog Number 7706-1024

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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 off in the pedicle of the patient.The tip was not able to be retrieved.An alternate device was used to complete the case.There were no additional patient impacts reported.

Manufacturer Narrative

Additional information in d4 (lot number), d10 and h6 (method).

Event Description

It was reported that during the procedure the tip of the tap broke off in the pedicle of the patient.The tip was not able to be retrieved.An alternate device was used to complete the case.There were no additional patient impacts reported.

Manufacturer Narrative

Additional information in b4, 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 a portion of the tip has fractured off.Additionally, an x-ray was provided, the x-ray shows the fractured tip inside the patient.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 off in the pedicle of the patient.The tip was not able to be retrieved.An alternate device was used to complete the case.The complaint is confirmed.The exact cause of this event can't be determine with the available information.

Event Description

It was reported that during the procedure the tip of the tap broke off in the pedicle of the patient.The tip was not able to be retrieved.An alternate device was used to complete the case.There were no additional patient impacts reported.

• Brand Name: TELLURIDE TAP CANNULATED 4.5MM
• Type of Device: TAP
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 10176269
• MDR Text Key: 195891614
• Report Number: 3012447612-2020-00323
• Device Sequence Number: 1
• Product Code: HWX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7706-1024
• Device Lot Number: LX-2968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other