MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD COMPOSITE SERIES SKULL CLAMP; ¿COMPOSITE SERIES¿

Catalog Number A3059

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

This is the first of two reports (same patient, same surgery, same product problem, different product id's).Linked to mfg report: 3004608878-2016-00154.A report was received that the a3101 mayfield composite series base unit and a3059 mayfield composite series skull clamp jolted or buckled twice during the procedure.There was no patient injury, however, the surgery was delayed by 1 hour while trying to identify what caused the movement / buckling.Additional information has been requested.

Manufacturer Narrative

Integra has completed their internal investigation on 19jul2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: engineering was able to partially confirm the customer complaint because the verbiage used to describe the problem was not clear.Thus, engineering interpreted the description of the problem as a slippage.The findings are as follows: all the skull clamps were assembled to the base unit and performed the wooden block test on each and no slippage was experienced.Checked the pressure of all the torque screws per tp454a1002 at 20, 40, 60, and 80 lbs within +/- 4 lbs.Tolerance of force.All the measurements were within the tolerances specified.Then the base unit¿s tension was inspected with the torque wrench as stipulated on its 1101 inspection checklist step 5b.With the transitional and base handle in its fully extended position (horizontal) and the closing handle locked, ensure the handle assembly does not move on tube, nor can the transitional rotate at 55 ft-lbs force and from the same position, verify the base handle is set to allow rotation or slippage at 75 ft-lbs force.The torque wrench was set at 55 ft-lbs and it moved down from its original location resulting the inspection to be a failure.The device history record for the unit(s) listed in this complaint under lot code/work order: (b)(4).Date of manufacture: 22 apr-2016.A total of (b)(4) skull clamps were produced of this lot and all passed the required inspection points with no associated mrr¿s, variances or rework.No service history is on file for this device.No manufacturing or design related trend has been identified.Conclusion: the root cause can be attributed to the base handle being out of adjustment as seen above.Integra life sciences recommends customers to send in their mf2 base units once a year for preventative maintenance.

• Brand Name: MAYFIELD COMPOSITE SERIES SKULL CLAMP
• Type of Device: ¿COMPOSITE SERIES¿
• 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: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5722671
• MDR Text Key: 48501074
• Report Number: 3004608878-2016-00153
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K142238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A3059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2016
• 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