MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC DRIVER, QUICK CONNECT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 7480147

Device Problem Disconnection (1171)

Patient Problem Laceration(s) (1946)

Event Date 02/10/2015

Event Type  Injury  

Event Description

It was reported that the patient underwent a fusion surgery.During the surgery, when the surgeon used the instrument to break off the set screw, the instrument slipped off the screw and caused a dural tear.It was noted that this instrument could have been damaged before this surgery due to normal wear and tear but had gone unnoticed.The surgeon fixed the dural tear and completed the procedure with no further complications.

Manufacturer Narrative

(b)(4).The device was not returned to the manufacturer for evaluation.

Manufacturer Narrative

Analysis of the returned device shows that visually confirmed approximately ~3-4mm of the instrument tips have been stripped, consistent with interface during usage.The hardness of the shaft is hrc 49.6 which is within print spec.The above findings are consistent with torsional overload.

• Brand Name: DRIVER, QUICK CONNECT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinnea rd.; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4572796
• MDR Text Key: 20020036
• Report Number: 1030489-2015-00422
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2015

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 Catalogue Number: 7480147
• Device Lot Number: SV12M038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2015
• Initial Date FDA Received: 03/05/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention