MAUDE Adverse Event Report: CONTRACT MANUFACTURER: MERCED MEDICAL MICRO PITUIT RNGR 2X6MM UP, BLK,180MM; RONGEURS

Model Number MF449R

Device Problems Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2015

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: on-going.Product will not be released for evaluation.

Event Description

On (b)(6) 2015 during right microlumbar diskectomy for herniated nucleus pulposus l5-s1 (right) with radiculopathy, the micro pituitary was discovered to have a missing upper jaw when it was removed from the disk space.Unable to locate the missing piece.Fluoroscopy was performed to confirm missing jaw not in surgical field or patient.Surgery was successfully completed with no patient injury.Device will not be released for evaluation.Complaint not reported to aesculap, inc by the end-user.Information received via user facility medwatch report.

• Brand Name: MICRO PITUIT RNGR 2X6MM UP, BLK,180MM
• Type of Device: RONGEURS
• Manufacturer (Section D): CONTRACT MANUFACTURER: MERCED MEDICAL; 36131 n. hazelwood dr.; ingelside IL 60041
• Manufacturer (Section G): CONTRACT MANUFACTURER: MERCED MEDICAL; 36131 n. hazelwood dr.; ingelside IL 60041
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5142170
• MDR Text Key: 28376546
• Report Number: 2916714-2015-00907
• Device Sequence Number: 1
• Product Code: HTX
• 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
• Reporter Occupation: Other
• Report Date: 09/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MF449R
• Device Catalogue Number: MF449R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2015
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other