MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA FASTSYSTEM STERILE FIELD POST; SURGICAL RETRACTOR

Catalog Number	4080
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fastsystem sterile field post (4080) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: evaluation found that the clamp jaw of the sterile field post was unstable when mounted on the test rail.The bolt had become flat at the bottom and must be replaced along with the washers.Root cause analysis: the complaint reported by the customer was confirmed as valid.Based on the evaluation by integra service and repair, the root cause was most likely use-error (closing the clamp with nothing inside).No manufacturing, workmanship, or material deficiency was identified for correction as a result of this complaint investigation.
Event or Problem Description
It was reported that the fastsystem sterile field post (4080) did not stay tightened when attached to the table during surgery.A delay of at least 30 minutes was reported as a result of looking for another retractor used to complete the surgery.The was no patient injury or death reported.

• Brand Name: FASTSYSTEM STERILE FIELD POST
• Common Device Name: SURGICAL RETRACTOR
• 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: 20370720
• Report Number: 3004608878-2024-00118
• Device Sequence Number: 6783057
• Product Code: GAD
• UDI-Device Identifier: 10381780270652
• UDI-Public: 0110381780270652106
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2024

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: 4080
• Device Lot Number: 6212276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• 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