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

Catalog Number 10244

Device Problems Device Maintenance Issue (1379); Component or Accessory Incompatibility (2897); Device Dislodged or Dislocated (2923)

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

Event Date 02/02/2016

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 post is rotating/ slipping during surgery.(b)(6) 2016 customer reports that a possible bowel resection was being performed.When pressure for retraction was applied device would not stay in place.No harm to patient.

Manufacturer Narrative

On (b)(6) 2016 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - the customer¿s complaint has been confirmed by engineering.During evaluation it was discovered that our test support arm was not clamping properly when inserted into the serrated clamp on the received unit.Per the application of force, the test support arm would rotate within the clamp.Furthermore, the test arm would rotate about the post under the application of force which seems to suggest a loss of clamping ability in the clamp¿s subassembly.There is a significant amount of scarring present on the outer surface of the received field post especially in between the two retaining rings which is a critical segment of the post on which the clamp subassembly primarily functions.The uniform wear pattern suggests an abrasive material may have been used along the surface of the field post which could potentially result in the removal of material and directly impact the clamping ability of the system as well.Furthermore, engineering noticed significant squeaking noise whenever the handle subassembly was being moved from the locked position to the unlocked position.Device history evaluation - device history record reviewed for this product id shows no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points with no associated (b)(4)¿s, variances or rework.Conclusion: upon receiving the unit once again, engineering did not observe any dysfunctional internal components which could possibly lead to the observed failure.The unit was taken apart and all replaced components were still in good condition with no signs of permanent deformation/destruction.Engineering proceeded to confirm the outer diameter on the field post due to the presence of excessive scarring which yielded unfavorable results.Measurements were taken on (b)(4) different planes along the post in-between the (b)(4) ¿(b)(4)¿ retaining rings¿.The measurements show much variation along each plane of the field post.Also there were certain areas on the post that were considerably undersized per specification ((b)(4)) with the worst case measuring at (b)(4)¿ below (b)(4).Furthermore, engineering noticed a significant variation in measurements taken along each plane with the worst-case being a (b)(4)¿ circumferential deviation.The combination of an undersized o.D and a non-circular post has a significant impact to the clamping ability of the ¿serrated clamp subassembly¿ on the post.It is postulated that any use of abrasive material used on these posts contributed to the outer diameter to be out of specification and resulted in a non-circular surface.The clamps are specifically set to function within the allowable o.D tolerance of the post ((b)(4)).Furthermore, without enough contact points between the inner diameter of the ¿.(b)(4) serrated clamp¿ and the outer diameter of the post, the clamps will easily rotate about the post due to lack of friction.During ils-cincinnati¿s assembly process three sections of the posts are inspected and verified to be conforming per print ((b)(4)).Moreover, the ¿serrated clamp subassembly¿ is specifically set to properly clamp onto our (b)(4) test post as well.As a result, if the o.D of the posts are altered by the end user, this will have a direct (b)(4) impact to the system¿s overall clamping ability.

• Brand Name: OMNI-FLEX STERILE FIELD POST
• Type of Device: 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: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5488853
• MDR Text Key: 39986050
• Report Number: 2523190-2016-00025
• Device Sequence Number: 1
• Product Code: FFO
• Combination Product (y/n): N
• PMA/PMN Number: K842762
• 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: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10244
• Device Lot Number: 154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2015
• 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: 53 YR