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

Catalog Number A1114A

Device Problem Unintended Movement (3026)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that it appeared to the physician that the torque screw on the mayfield standard infinity skull clamp (a1114a) "moved" and the swivel lock remained locked despite being moved to the unlocked position.It is unknown if there was patient involvement; however, no patient injury or surgical delay has been reported.

Manufacturer Narrative

The standard infinity skull clamp (a1114a) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - evaluation found no device deficiencies that would have contributed to the reported complaint and was unable to duplicate the reported movement/slippage except that the unit had both rotational and lateral movement and a residue buildup was present.This rotational and lateral movement was observed in the lock, not the torque screw as reported by the customer; thus this movement is unrelated to the reported complaint.Upon disassembly, it was noted the index knob and lock needed new components added to replace worn internal parts.Unit was machined to have heli-coils added to the large starburst threads.General maintenance and cleaning performed and new components were added to replace worn internal parts.Root cause analysis - evaluation found no device deficiencies that would have contributed to the reported complaint.Repairs was unable to duplicate the reported movement/slippage.Unit received preventive maintenance 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: STANDARD 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: 13252850
• MDR Text Key: 283778308
• Report Number: 3004608878-2022-00008
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K051440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1114A
• Device Lot Number: 194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2019
• 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