MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA HARRINGTON SWEETHEART SWIVEL RETRACTOR, 2; SURGICAL RETRACTOR

Catalog Number 3794

Device Problem Mechanics Altered (2984)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2022

Event Type  malfunction  

Manufacturer Narrative

The harrington sweetheart swivel retractor (3794) was returned to integra service and repair for evaluation: failure analysis: evaluation of the mayo swivel retractor found that the.375 clamp was damaged, and some small parts were worn.The clamp and small parts were renewed.The unit was tagged with an instance number and function test was carried out.Root cause analysis: based on evaluation by integra service and repair, the clamp was found to be damaged, likely causing the alleged issue of the clamp not being able to be fixed to the metal rod of the blade, and thus damaging the retractor in the process.This damage was most likely caused by either a lack of proper care for the product to prevent damages, or simply accidental damaging of the product.No further investigation required based on the acceptability of risk.This issue and similar events are monitored and trended.

Event Description

This is 4 of 4 reports, linked to mfg numbers: 3004608878-2022-00033, 3004608878-2022-00035, 3004608878-2022-00036, a facility reported that during and after a procedure, the harrington sweetheart swivel retractor (3794) was damaged due to a defective clamp.It was reported that the procedure was finished in an "old-school" way of having the intern hold some hooks and retractors.The device was in contact with the patient.It was reported that the event led to an increase in surgery time of ¿around 30 minutes¿; however, no patient injury or death occurred.

Event Description

N/a.

Manufacturer Narrative

Updated fields: d4 (lot#), d9, g3, g6, h2.H3, h11.Corrected fields: d9, h6 (investigation findings), h10.Corrected h10: the evaluation results reported on initial mdr was incorrectly documented for this product.The following below replaces previous evaluation results: the harrington sweetheart swivel retractor (3794) was later returned for failure analysis: failure analysis of the swivel retractor noted minor cosmetic scratches on the proximal end of the retractor rod, where the rod is inserted to the frame clamp.The retractor blades functioned as intended without issue or defect.Root cause analysis found incidental scratches (cosmetic) at the proximal end of the retractor connection rod were verified, most likely caused by improper attachment to the snap clamp assembly or omni-tract frame.No further investigation is required based on the acceptability of risk.At present, we consider this complaint to be closed.

• Brand Name: HARRINGTON SWEETHEART SWIVEL RETRACTOR, 2
• Type of Device: SURGICAL RETRACTOR
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13652609
• MDR Text Key: 291209156
• Report Number: 3004608878-2022-00037
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3794
• Device Lot Number: 187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1