MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; N/A

Catalog Number A1059

Device Problems Material Disintegration (1177); Out-Of-Box Failure (2311); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

This is the seventh of eight reports (same distributor, same product problem, different product ids).During incoming inspection of goods by the distributor, metal powder was generated when measuring pressure on the mayfield modified skull clamp.There was no patient involvement.Linked to mfr reports: 3004608878-2016-00307, 3004608878-2016-00306, 3004608878-2016-00308, 3004608878-2016-00310, 3004608878-2016-00309, 3004608878-2016-00311, 3004608878-2016-00313.

Manufacturer Narrative

This investigation was completed on 12/15/16.Device history record reviewed for this product id under lot code/work order 157/1462575 manufactured on 08/05/16 show no abnormalities related to reported incident found.This device passed all required inspection points with no associated mrr¿s, variances or rework.No previous service history is on file.During the pressure test portion of the inspection, metal shavings were observed in the threads of the torque screws.In summary, engineering and quality were able to verify the customer complaint.Also, it is noted that the helicoil migrates out of the ratchet after subjecting the skull clamp under load for a certain number of cycles (number varies in skull clamps).Thus, a corrective action has been opened to investigate this failure as the metal powder formation is precursor to the helicoil moving inside the ratchet arm.The skull clamp¿s ratchet extension has a detailed assembly instruction that outlines the process of installing the helicoil.The last step in the work instructions requires the operator to use a ¾-16 thread gage to verify fit.All products in question were subjected to these quality controls during manufacture.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: N/A
• 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: 6102186
• MDR Text Key: 60306352
• Report Number: 3004608878-2016-00312
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: A1059
• Device Lot Number: 1462575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2016
• 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