MAUDE Adverse Event Report: ZIMMER SPINE POWER KNOB ROD REDUCER SHORT

Model Number N/A

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2016

Event Type  Injury  

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.Report two of three for the same event; see also 0002184052-2016-00156 and 00158.

Event Description

It was reported that during surgery, while inserting the 5.5 screw, the screw head got dis-mantled from the body.The screw broke while loading it on the driver.Therefore, another screw was used.In addition, the power knob reducer got stuck during the surgery and was not usable.And, the rod bender was not in the part of the set and should have been.It was confirmed there was a surgical delay longer than 30 minutes.

• Brand Name: POWER KNOB ROD REDUCER SHORT
• Type of Device: ROD REDUCER
• 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: 5857508
• MDR Text Key: 51502648
• Report Number: 0002184052-2016-00157
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: PK132884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• 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: 3567-10
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 72