MAUDE Adverse Event Report: MSD BARTLETT MFG MANUAL ORTHOPEDIC SURGICAL INSTRUMENT; PROBE

Catalog Number 803-292

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2014

Event Type  malfunction  

Event Description

It was reported that the patient underwent a posterior spinal surgical procedure.It was reported that approximately 1 inch of the tip of the shaft broke off.The tip was removed.No patient complications were reported.

Manufacturer Narrative

Additional info: macroscopic examination confirms probe bent in multiple locations, with probe tip breakage approx.~23mm from the probe tip end.Optical examination reveals a fairly tortuous fracture surface, consistent with bend stress overload.The above observations are consistent with bend stress overload.

Manufacturer Narrative

(b)(6): neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

• Brand Name: MANUAL ORTHOPEDIC SURGICAL INSTRUMENT
• Type of Device: PROBE
• Manufacturer (Section D): MSD BARTLETT MFG; 2975 brother blvd; bartlett TN 38133
• 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: 3963798
• MDR Text Key: 4605496
• Report Number: 1030489-2014-03331
• Device Sequence Number: 1
• Product Code: HXB
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 803-292
• Device Lot Number: ID09D002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2009
• 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