MAUDE Adverse Event Report: DEPUY SPINE INC IS ROD SIDE CUTTER; INSTRUMENT, CUTTING, ORTHOPEDIC

Catalog Number	205027
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The is rod side cutter was returned for evaluation.Visual examination of the rod cutter revealed that the tip of the rod cutter had become chipped and plastically deformed across the cutting edge of the rod cutter blade.A review of the device history record for the reported lot of the reported products did not find any anomalies in the release of these devices.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause of the rod cutter tip becoming chipped and plastically deformed across the cutting edge of the rod cutter blade cannot be positively determined.However, the noted damage suggests that the tip of the rod cutter most likely was subjected to an unanticipated high load when cutting a rod resulting in the tip to chip and become plastically deformed across the cutter edge of the blade.No issues were identified in the manufacturing and release of this device that could have contributed to the problem reported by the customer.As such, the complaint will be closed with no further action.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
Cutting are at the tip of instrument broken.

• Brand Name: IS ROD SIDE CUTTER
• Common Device Name: INSTRUMENT, CUTTING, ORTHOPEDIC
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7286165
• Report Number: 1526439-2018-50154
• Device Sequence Number: 16507785
• Product Code: HTZ
• UDI-Device Identifier: 10705034001258
• UDI-Public: 10705034001258
• 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
• Type of Report: Initial
• Report Date (Section B): 02/01/2018

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: No Information
• Device Catalogue Number: 205027
• Device Lot Number: HM39988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Initial Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1