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

Catalog Number 10244

Device Problems Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)

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

Event Date 10/06/2015

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

Doctor was performing an anterior hip replacement.Customer reported an issue with the omni on his third case - (b)(6) 2015.The support arm connector on the sterile field post rotates and toggles while omni retractor is in place, which caused the wishbone to become unstable and would not allow the retractor to keep appropriate exposure of operative site.Doctor had additional cases after that and the problem couldn't be replicated.".

Manufacturer Narrative

Integra has completed their internal investigation on 01/06/2015.The investigation included: methods: evaluation of actual device review of device history records review of complaints history results: device history record reviewed for this product id (10244) lot #157 manufactured on september 29, 2015 show no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points with no associated mrr¿s, variances or rework, see below.The following work orders encompass the devices manufactured with this lot code, see below.No service history is on file for this device.A two year look back in trackwise for this reported failure and or related to "post rotates and toggles during surgery " for this product id shows that 4 complaints were received including this case.No new design or manufacturing trends have been identified conclusion: in summary, upon further investigation into the customer¿s complaint, engineering noticed the s.F.Clamp subassembly (p/n 4088021) was not functioning properly as designed.The s.F clamp subassembly primarily comprises of two.75 serrated clamps (p/n 4044011), 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 and 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 (p/n 4047011) does not fully sit on the bushing (p/n 4103011) between the.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.Capa has been issued to address the non-conformance above, and to help determine the actual root cause and adopt measures to help prevent any future reoccurrences.

Event Description

(b)(6) 2015 customer reports an anterior hip replacement was being performed when the event occurred.

• 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: 5211660
• MDR Text Key: 30839402
• Report Number: 2125289-2015-00006
• 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: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/06/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: 10244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 11/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2015
• 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