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

Catalog Number A2114

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was not yet received by the manufacturer for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A nurse reported that the a2114 mayfield infinity xr2 skull clamp, the 80# torque screw came apart.Additional information received on 09jan2020 reported that there was patient contact however, no injury was reported.The product problem was discovered after the procedure, when removing the unit from patient¿s head.The screw did not fall in the surgical site.There was no delay in surgery.

Manufacturer Narrative

Device identifier # 10381780253761.The device was returned for evaluation.The device history record (dhr) was reviewed with no abnormalities related to the reported failure.The device passed all required inspection points with no associated mrr's, variances or rework.The complaint was confirmed from the evaluation.The clamp received in with the torque knob being disassembled and missing parts.Unit received with the left and right pawls worn and without pedi rocker arm or suit case.General maintenance and cleaning required.The observed condition is consistent with improper handling of the unit.The definite root cause cannot be reliably determined.

• 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
• MDR Report Key: 10277466
• MDR Text Key: 202957450
• Report Number: 3004608878-2020-00072
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K090506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A2114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 02/26/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1