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

Catalog Number A1059

Device Problems Device Operates Differently Than Expected (2913); Material Protrusion/Extrusion (2979)

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

Event Date 01/30/2017

Event Type  malfunction  

Event Description

The hospital sent back the a1059 to the distributor to fix the device because the helicoil was protruding outwards.There was no patient involvement reported.

Manufacturer Narrative

Integra has completed their internal investigation on may 15, 2017.Results: product was not received for inspection, however a corrective action has been issued to investigate this reported failure (skull clamp helicoils coming off during pressure testing).Dhr review; no abnormalities relate to reported incident found nor where there any variances, mrr¿s or reworks associated with this work order# and lot#.No service history is on file for this device.Complaints history; a corrective action has been issued to further investigate this reported failure and as such this project will include the occurrence.Conclusion: the device in question was not received for evaluation therefore the root cause to the end users experience could not be determined.This complaint will be reopened should we receive product.

Manufacturer Narrative

Investigation completed 08/01/2017.Work order# 103725/ lot# 139.The device history record for this unit shows that this part was manufactured on 11/25/2013.No abnormalities related to reported incident were found, nor were there any variances, mrr¿s or reworks associated with this work order number and lot number.No service history is on file for this device.The customer removed the helicoil and returned the actual component (skull clamp helicoils coming off during pressure testing) that were removed from skull clamps repaired or in question.This customer sent in 21- gs127¿s (helicoils) that were removed from skull clamps repaired or in question.Due to how these helicoils were removed the heli coil threads were damaged thus we are unable to perform a dimensional inspection.We are also unable to trace these parts back to the device that it was removed from as these 21 pieces were received in one bulk bag with no supporting information.Root cause is undetermined at this time.

• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6509244
• MDR Text Key: 73514169
• Report Number: 3004608878-2017-00131
• 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,Followup
• Report Date: 04/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Device Lot Number: 103725/139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2013
• 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