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

Catalog Number A2114

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the ratchet plunger knob mechanism of the mayfield infinity xr2 skull clamp (a2114 ) was broken.It is unknown if there was patient involvement, or if the device failure led to patient injury, or surgical delay.

Manufacturer Narrative

Unique device identifier (udi): (b)(4).Device history record (dhr) - the dhr documentation showed no abnormalities related to the reported failure.The mayfield skull clamp was returned for evaluation: failure analysis: the unit was received with the left and right pawls worn and the lock was difficult to lock/unlock.Unit required general maintenance and cleaning.Root cause: the reported complaint was confirmed via inspection.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

N/a.

• 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: 11046369
• MDR Text Key: 223789741
• Report Number: 3004608878-2020-00748
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

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: 12/10/2020
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 12/23/2020
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1