MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Catalog Number A1059

Device Problems Material Disintegration (1177); Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

This is the first of three reports (same product id, same product problem, same distributor).Linked to mfg reports: 3004608878-2016-00212 and 3004608878-2016-00213.A report was received from the distributor that the a1059 mayfield skull clamp had metal powder generated when applying pressure.The problem was found during the inspection of incoming goods.There is no patient contact or patient injury.

Manufacturer Narrative

Integra has completed their internal investigation on 07 sep 2016.The investigation included: methods: evaluation of actual device, review of device history records, review of complaint history.Results: evaluation of device: it was observed that metal powder generated when applying pressure (sn¿s: (b)(4)).Device history record reviewed for these product ids under lot code/work order 161/139300 manufactured on 03/23/16 show no abnormalities related to reported incident found.These devices passed all required inspection points with no associated mrr¿s, variances or rework.No previous service history is on file.Capa has been issued to further investigate the reported failure based around complaints associated to "scrap metal /powder comes out /metal burrs" for this product family.The helicoil displacement issue reported on the returned devices was able to be confirmed by integra engineering and quality.Capa has been opened to perform comprehensive investigation.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.These will be monitored for trending.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEMS
• 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: 5876869
• MDR Text Key: 53050366
• Report Number: 3004608878-2016-00211
• 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: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: A1059
• Device Lot Number: 161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2016
• 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