MAUDE Adverse Event Report: DEPUY SPINE INC 8MM OSTEOTOME STRAIGHT

Model Number	288205052
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2018
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 osteotome looks very worn and chipped due to lots of use and needs to be replaced.Patient consequence?: no.Is the information being submitted for this complaint all the details that are known/available regarding this event?: yes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination of the returned device exhibited significant signs of clinical use.The tip of the osteotome is damaged and the device exhibits severe indentation marks, consistent with the damage occurred from general usage over a period.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 8mm osteotome straight becoming worn cannot be positively determined.However, the damage can be attributed to the general wear causing the tip to get damaged over a period.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.

• Brand Name: 8MM OSTEOTOME STRAIGHT
• Common Device Name: OSTEOTOME
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7359586
• Report Number: 1526439-2018-50189
• Device Sequence Number: 1769235
• Product Code: HWM
• UDI-Device Identifier: 10705034220529
• UDI-Public: (01)10705034220529
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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 Model Number: 288205052
• Device Catalogue Number: 288205052
• Device Lot Number: PG248064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 04/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1