MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD RUSKIN RONG 7-1/4 STR 5MM; CARDIOVASCULAR BONE

Catalog Number	230210
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The following was reported via uf/importer report# (b)(4): "after using rongeur, it was noticed that a screw was missing from the instrument.Search was done by staff, but not found.X-ray was done of surgical site and not found.Instrument removed from field and sent with repair tag to sterile processing department." "original intended procedure: orif with local autogenous bone graft for left clavicular shaft fracture nonunion".No patient injury or surgical delay has been reported.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h10, h11.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Corrected field: d4 (product id).Medwatch report indicates model#/product id 320210 (cooley vascular clamp); however, the event description reports a ruskin rongeur.The report of item "320210" may have been a typo, as 230210 ruskin rongeur is one digit off.As a result, we have updated our investigation record to match the reported event description of 230210 rongeur.The product has not been returned for evaluation and no information has been received form the customer after several attempts.Lot number information has not been provided; therefore, a review of the device history record (dhr) could not be reviewed.A definitive root cause cannot be determined.The issue of a missing screw may be the result of rough handling or environmental damage.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.
Additional Manufacturer Narrative
Updated fields: d4 (udi#), g3, g6, h2, h6, h11 corrected fields: d2b, pma/510(k) #.
Event or Problem Description
N/a.

• Brand Name: RUSKIN RONG 7-1/4 STR 5MM
• Common Device Name: CARDIOVASCULAR BONE
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19621302
• Report Number: 3014334038-2024-00137
• Device Sequence Number: 8084706
• Product Code: HBG
• UDI-Device Identifier: 10381780142782
• UDI-Public: 10381780142782
• Combination Product (Y/N): N
• PMA/510(K) Number: K902818
• 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,Followup
• Report Date (Section B): 11/04/2024

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: 230210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 07/09/2024; 08/01/2024; 10/15/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 07/09/2024; 08/05/2024; 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 62 KG