MAUDE Adverse Event Report: DEPUY SPINE INC STRAIGHT 8MM CHISEL; CHISEL, SURGICAL, MANUAL

Catalog Number	274279000
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual examination found that the distal tip of the chisel had nicked at microscopic level and it had scratches on the tip.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the chisel¿s distal tip nicking cannot be positively determined.However, noted damage suggests that the chisel was likely subjected to inadvertently forces during the process, resulting in the distal tip of chisel undergoing nicking.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 were found, 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.
Event or Problem Description
Tip of chisel defective after first use.

• Brand Name: STRAIGHT 8MM CHISEL
• Common Device Name: CHISEL, SURGICAL, MANUAL
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7682787
• Report Number: 1526439-2018-50663
• Device Sequence Number: 1553459
• Product Code: FZO
• UDI-Device Identifier: 10705034191874
• UDI-Public: (01)10705034191874
• Combination Product (Y/N): N
• 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 Caregivers
• Type of Report: Initial
• Report Date (Section B): 04/24/2018

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 Catalogue Number: 274279000
• Device Lot Number: GM4581001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 07/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1