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

Catalog Number A2114

Device Problem Physical Resistance/Sticking (4012)

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

Event Type  malfunction  

Manufacturer Narrative

Unique device identifier (udi): (b)(4).Device history record - the dhr documentation showed no abnormalities related to the reported failure.Mayfield skull clamp (product id a2114) was returned for evaluation: failure analysis: unit had one of the pawls broken on the plunger knob.This was not allowing it to fully engage on the ratchet extension.Unit will be repaired and general maintenance and cleaning is also required.Root cause: the reported complaint was confirmed via inspection of the unit.Unit had one of the pawls broken on the plunger knob.This was not allowing it to fully engage on the ratchet extension.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

A facility reported that the ratchet of the mayfield infinity skull clamp (product id a2114) was sticking and they have to manually and forcefully close the plunger to engage the teeth.It is unknown if there was patient involvement or if the device failure led to patient injury or surgical delay.

• 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: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 11225917
• MDR Text Key: 233477254
• Report Number: 3004608878-2021-00028
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2020

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: 09/09/2020
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 01/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2013
• 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