MAUDE Adverse Event Report: DEPUY SYNTHES SPINE 2MM STRAIGHT MICROPITUITARY; RONGEUR

Catalog Number 292904201

Device Problem Break (1069)

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

Event Date 03/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The tip of the instrument broke while the surgeon was using it to remove soft tissue from the surgical site.The broken piece which had fallen inside the patient was easily removed with a forcep.

Manufacturer Narrative

(b)(4).One (1) 2mm straight micropituitary [product code: 2929-04-201, lot no: 1010kw] was returned to the customer quality unit (cqu) for evaluation.Visual examination at the macroscopic level revealed that the fracture was located at the distal working end of the device.The fracture analysis report reveal rough surfaces and plastic deformation across the entirety of both fractured surfaces.These features are consistent with a static overload failure that severed the upper jaw from the device.No material defects or other abnormalities were observed in this analysis.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.No emerging trends were found requiring further actions.A definitive root cause for the micropituitary tip becoming broken cannot be positively determined.However, the fracture analysis report indicated that the device¿s jaw underwent a static overload failure.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2MM STRAIGHT MICROPITUITARY
• Type of Device: RONGEUR
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6453508
• MDR Text Key: 71586395
• Report Number: 1526439-2017-10227
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 292904201
• Device Lot Number: 1010KW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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