MAUDE Adverse Event Report: DEPUY SPINE INC SPOT 2MM, 45 UP ANGLE MICROPI; RONGEUR

Model Number	292904202
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 or Problem Description
The following was reported: item 2929-04-201: the screw holding this instrument together was missing when the instrument was taken out of the pan.It was therefore not usable.Item 2929-04-202: the tip of this instrument bent and eventually broke off as the surgeon was using this instrument to remove small bone fragments.No piece fell into the patient but the missing piece was discarded.Item 2867-25-020: the tip of this screw driver was stripped and twisted as the surgeon was trying to remove a screw which was very hard to remove.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination of the micro pituitary revealed general wear and tear to the device due to numerous uses over time.It was noted that one of the jaws of the pituitary was broken.The broken jaw was not returned.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 jaw of the device breaking cannot be determined from the sample and the information provided.A potential root cause may be high forces inadvertently placed on the jaws of the device during impaction, exerting enough force to result in the fracture.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, 45 UP ANGLE MICROPI
• Common Device Name: RONGEUR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8558449
• Report Number: 1526439-2019-51579
• Device Sequence Number: 16662561
• Product Code: HTX
• UDI-Device Identifier: 10705034225685
• UDI-Public: (01)10705034225685
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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
• Operator of Device: Health Professional
• Device Model Number: 292904202
• Device Catalogue Number: 292904202
• Device Lot Number: KW1543341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1