MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD BRUNS CURETTE 9 STR SIZE 2; N/A

Catalog Number	240124
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility reported that during curettage and grafting right proximal humerus cyst, the bruns curette 9 str size 2 (240124) broke off in a patient intra-operatively.It was reported that the tip could not be retrieved; however, there has been no reported post-operative complications.No information has been provided as to whether there was surgical delay.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow up report will be submitted.
Additional Manufacturer Narrative
The bruns curette 9 str size 2 (240124) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.The issue of breaking may be the result of rough handling or wear.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: BRUNS CURETTE 9 STR SIZE 2
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17330114
• Report Number: 3014334038-2023-00107
• Device Sequence Number: 6534316
• Product Code: LXH
• UDI-Device Identifier: 10381780187363
• UDI-Public: 10381780187363
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/05/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 240124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 08/01/2023; 09/05/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/08/2023; 09/05/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown