MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY XR2 SKULL CLAMP

Catalog Number A2114

Device Problems Crack (1135); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The starburst teeth were chipped.The issue was found during the inspection for incoming goods by the distributor.There was no patient involvement.

Manufacturer Narrative

Integra has completed their internal investigation on 21jun2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: the unit was inspected and some of the teeth on the starburst were found chipped.Device history record reviewed for this product id lot code/work order: (b)(4) manufactured on 01/29/2016 show no abnormalities related to the reported failure.These devices passed all required inspection points with no associated mrr¿s, variances or rework.No service history is on file for this device.A two year lookback in the complaint system for this reported failure and or related to "starburst tooth was chipped " for this product id shows that three complaints were received including this case.All three complaints were reported by the same customer.No new design or manufacturing trends have been identified, however in a means of continuous quality improvement dco8823 has been routed to revise the related router to include a visual inspection of the casting by the operator prior to machining.The customer's complaint was verified.The root cause could not be accredited at this time.This seems to be a casting defect and the vendor will be informed of such.Also, dco 8823 will be routed to revise the router to include a visual inspection of the casting by the operator prior to machining.The part still functions optimally; however, its longevity is affected.This issue will be monitored for trending.

• Brand Name: MAYFIELD INFINITY XR2 SKULL CLAMP
• Type of Device: MAYFIELD
• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5638439
• MDR Text Key: 45010019
• Report Number: 3004608878-2016-00110
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K130389
• 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: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: A2114
• Device Lot Number: 159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2016
• 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