MAUDE Adverse Event Report: ZIMMER SPINE TORQUE LIMITING HANDLE 90 IN-LBS

Model Number N/A

Device Problem Device Inoperable (1663)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Report two of two for the same event; see also 0002184052-2016-00205.

Event Description

The sales associate reported a stripped driver and torque handle.The handle did not torque and stripped the driver.No further information was provided.

Manufacturer Narrative

The returned torque handle was evaluated.The torque output was found to be out of tolerance and when disassembled, significant wear to the internal components was found.A review of the manufacturing records did not identify any issues which would have contributed to this event.This issue is being investigated via capa.

• Brand Name: TORQUE LIMITING HANDLE 90 IN-LBS
• Type of Device: TORQUE LIMITING HANDLE
• Manufacturer (Section D): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer (Section G): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer Contact: michelle cole ; 7375 bush lake road; minneapolis, MN 55439 ; 9528325600
• MDR Report Key: 5933043
• MDR Text Key: 54084029
• Report Number: 0002184052-2016-00206
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK150896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 07.02053.001
• Device Lot Number: 63028598
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 09/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention