MAUDE Adverse Event Report: DEPUY SPINE INC SPOT 2MM STRAIGHT MICROPITUITA; RONGEUR

Catalog Number 292904201

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on an unknown date, during routine incoming inspection of a loaner set, it was observed that the spot straight was broken.There was no patient involvement.This complaint involves one (1) device.

Manufacturer Narrative

Product complaint # (b)(4).Udi: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual examination of the straight micropituita revealed that the handle of the device was broken at the hinge joint.It was noted that the device was very aged based on the surface marks and wear to the device.Fracture analysis was subsequently performed on the broken device.Optical imaging of the fractured surface of the device reveals a rough surface.This indicates a single, sharp, heavy load being placed on the distal end of handle.No material defects of 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.The root cause of the handle of the device breaking cannot be determined from the sample and the information provided.The results of fracture analysis have determined that a probable root cause is static overload failure due to a single, sudden, unexpectedly high force placed on the handle.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, 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: SPOT 2MM STRAIGHT MICROPITUITA
• Type of Device: RONGEUR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9251528
• MDR Text Key: 179766783
• Report Number: 1526439-2019-52312
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 10705034225678
• UDI-Public: 10705034225678
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292904201
• Device Lot Number: KW1346346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 11/21/2019
• Supplement Dates FDA Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1