MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD RETRACTOR, 4 BLUNT - JARIT; N/A

Catalog Number	205111
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
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 information was received via medwatch/mdr report# mw5118724: after surgery finished and the patient was out of the operating room, scrub tech was cleaning up and noticed that a screw was loose on a miltex retractor and attempted to tighten the screw.In doing so, the screw and hinge portion of the retractor fell off.In inspection of the whole miltex, the screw-hole of the hinge was missing less than 1mm portion of metal.A follow-up was made to the initial reporter to identify the serious injury/invention required reported on mw5118724.The reporter confirmed that no serious injury or medical intervention was required during this event.The reporter confirmed that the product problem was discovered after the surgery.No patient injury or surgical delay occurred.It was not suspected that any part broke in the patient.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated field: d4 (udi#), d9, g3, g6, h2, h3, h10.The retractor, 4 blunt - jarit (205111) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and the device history record (dhr) could not be reviewed.The customer reported that the item was discarded after photos were taken.Visual evaluation of the images provided by the customer indicated that the retractor had a broken screw hole.The reported complaint was confirmed.This damage may be the result of wear or rough handling/environmental damage.

• Brand Name: RETRACTOR, 4 BLUNT - JARIT
• 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: 17385889
• Report Number: 3014334038-2023-00115
• Device Sequence Number: 15028224
• Product Code: GAD
• UDI-Device Identifier: 10381780373032
• UDI-Public: 10381780373032
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 205111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/14/2023
• 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