MAUDE Adverse Event Report: DEPUY SPINE INC AETI FLAT CUR 11 X15 DEG; CURETTE

Catalog Number	630041115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Libertas: broken instrument.
Additional 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 inspection of the returned device found no evidence of device breakage.The cutting edge of the device was still sharp.The overall complaint was not confirmed.A manufacturing related potential cause was not suspected, no manufacturing record evaluation is required.The overall complaint was not confirmed as there was no evidence of device breakage.There was nothing identified that could have contributed to the complaint condition.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.

• Brand Name: AETI FLAT CUR 11 X15 DEG
• Common Device Name: CURETTE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9245743
• Report Number: 1526439-2019-52306
• Device Sequence Number: 1814537
• Product Code: HTF
• UDI-Device Identifier: 10705034227191
• UDI-Public: 10705034227191
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 630041115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1