MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC MANUAL ORTHOPEDIC SURGICAL INSTRUMENT; TAP, BONE

Catalog Number EX0213060

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2013

Event Type  malfunction  

Event Description

It was reported that the patient underwent a spinal surgical procedure at t10- pelvis.It was reported that the tip of the tap had a guidewire stuck and the guidewire could not be removed from the tap.No patient complications were reported.

Manufacturer Narrative

(b)(4): the device was returned for evaluation which found: visual and optical examination of instrument confirms tip of the tap is cracked; the cracks are ~1mm in length and splayed in multiple locations.The guidewire is unable to be removed from the tap.Tip splay or trumpeting effect and a bent/jammed guidewire is indicative of off-axis use of the tapping instrument with respect to guidewire.The observations are consistent with off-axis use of tap with respect to the guidewire.

• Brand Name: MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
• Type of Device: TAP, BONE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea 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: 3648175
• MDR Text Key: 4350816
• Report Number: 1030489-2014-00623
• Device Sequence Number: 1
• Product Code: HWX
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX0213060
• Device Lot Number: TI13C040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2013
• Date Manufacturer Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2013
• 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