MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA UNIVERSAL COMPACT H.R.ASSEMBLY; N/A

Catalog Number	UCHRA
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported that the screws on the universal compact h.R.Assembly (uchra) are short and do not even reach the edge of the frame when screwed in completely.When starting the surgery and fixing the frame, the black supports of the screws came loose because they did not carry far enough.As a result, we almost couldn¿t continue the surgery.To finalize the procedure, screws from the biotechnical dept.Were used to mount the instrument in a correct way.
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 universal compact h.R.Assembly (uchra) was returned for evaluation: failure analysis - the inspection of the returned device confirms the issue reported by the customer.The post fiber screws were confirmed to be too short and have been replaced.Root cause - the root cause is most likely due to improper repair by service on the prior repair.It is unclear why this apparent mistake was made by service, but they have been notified of the issue and have addressed it via the new evaluation and repair of this device.No further action is required as no manufacturing, workmanship, or material deficiency was identified for correction as a result of this complaint investigation.
Event or Problem Description
N/a.

• Brand Name: UNIVERSAL COMPACT H.R.ASSEMBLY
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 20858425
• Report Number: 3004608878-2024-00149
• Device Sequence Number: 20978692
• Product Code: HAW
• UDI-Device Identifier: 10381780252368
• UDI-Public: 10381780252368
• Combination Product (Y/N): N
• PMA/510(K) Number: K160811
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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: UCHRA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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