MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC SCREWDRIVER

Catalog Number 5584111

Device Problem Dull, Blunt (2407)

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

Event Date 06/03/2019

Event Type  malfunction  

Manufacturer Narrative

The product was not returned to the manufacturer for evaluation; hence, a definitive root cause for the reported event could not be identified.If information is provided in the future, a supplemental report will be issued.

Event Description

Type of procedure: removal of spacer from l4-l5; posterior hardware l3, l4, l5 transforaminal lumbar interbody fusion(tlif), l4-l5 posterior decompression it was reported that intra-op, the product was damaged during removal of screws.The product did not work properly and had a dull stripped driver head.This product came in contact with the patient.No patient complications were reported.

Manufacturer Narrative

Product analysis: visual and optical analysis revealed the tip of the inner shaft has been stripped out.The majority of the damage appears to be located in the first 1.5mm of the tip and there is some damage to the threads of the out shaft.The function of the locking mechanism works as intended.This type of damage is consistent with the driver head not being fully seated to the screw.This is consistent with torsional overload due the driver head not being fully engaged into the screw.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SCREWDRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8754852
• MDR Text Key: 149939196
• Report Number: 1030489-2019-00688
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5584111
• Device Lot Number: RS12F018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 07/11/2019
• Supplement Dates FDA Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1