MAUDE Adverse Event Report: INTEGRA BURLINGTON, MA, INC. STANDARD WISHBONE FRAME ARM; SURGICAL RETRACTOR

Catalog Number 10269

Device Problems Device Slipped (1584); Component or Accessory Incompatibility (2897)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

Customer initially reports hinge does not hold wishbone in place.(b)(6) 2015 no further information available.Two of two associated complaints.

Manufacturer Narrative

On 07/23/2016 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - the customers¿ complaint noted above has been confirmed.The customer sent in their omni-flex sterile field post and support arm although the only defective unit was their sterile field post.The support arm functions as intended when attached to the sterile field post with no observation of unwanted movement affecting the support arm.The serrated s.F clamp on their field post does lock onto the post clamp weld assembly but rotates on the post when a substantial amount of force is applied.Furthermore the clamp¿s subassembly handle does not align parallel to the field post in both locked and unlocked positions.Although in the unlocked position force is required to cause the misalignment.Findings/observations outside the complaint: there is visible wear and tear on the returned unit which is expected due to regular usage.Device history evaluation - device history record reviewed for the product id's listed below show no abnormalities related to the reported failure.These devices passed the required inspection points with no associated mrr¿s, variances or rework.No service history is on file for these devices.Conclusion: upon further investigation into the customer¿s complaint, engineering noticed the s.F.Clamp subassembly was not functioning properly as designed.The s.F clamp subassembly primarily comprises of two.75 serrated clamps which lock together when the handle is placed in the locked position.In the locked position, the starburst teeth do fully engage with no visible gaps present yet the handle does not align parallel to the field post.In the unlocked position with the application of force on the clamp¿s handle, the starburst teeth do fully engage as well and the handle remains unparalleled to the post, yet the cam body does not fully sit on the bushing between the upper.75 serrated clamp and cam body as it should.A dysfunctional, likely bent, internal component within the.75 serrated clamp assembly is likely the main cause for the s.F clamp subassembly not properly tightening onto the field post.The cam body is supposed to fully sit on the bushing at all times in both locked and unlocked positions.The handle should always remain parallel to the field post when fully rotated to either end.The handle should only have the ability to rotate between 0° and 180°, even with the application of force.

• Brand Name: STANDARD WISHBONE FRAME ARM
• Type of Device: SURGICAL RETRACTOR
• Manufacturer (Section D): INTEGRA BURLINGTON, MA, INC.; 22 terry avenue; 22 terry avenue; burlington MA 01803
• Manufacturer (Section G): INTEGRA BURLINGTON, MA, INC.; 22 terry avenue; burlington MA 01803
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5267067
• MDR Text Key: 32908314
• Report Number: 1222895-2015-00047
• Device Sequence Number: 1
• Product Code: FFO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2009
• 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
• Patient Age: 84 YR