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

Model Number A1114

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

This is 1 of 3 reports linked to mfg report numbers: 3004608878-2021-00666.3004608878-2021-00667.It was reported that the two pin swivel side on the mayfield infinity skull clamp (a1114) would not rotate when it was attached to the patient and the swivel knob was unlocked.No patient injury or surgical delay has been reported.

Manufacturer Narrative

The mayfield infinity skull clamp (a1114) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.The investigation of the returned device showed that the reported complaint was confirmed from the evaluation.The lock was sticking, the unit had rotational and lateral movement and a residue buildup was present.The unit needs repair, pm, replacement of worn parts and cleaning.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: MAYFIELD INFINITY SKULL CLAMP
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12952492
• MDR Text Key: 285700467
• Report Number: 3004608878-2021-00665
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253549
• UDI-Public: 10381780253549
• Combination Product (y/n): N
• PMA/PMN Number: K051440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2021

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 Model Number: A1114
• Device Catalogue Number: A1114
• Device Lot Number: 177(2017)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2015
• 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