MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD 2000 SKULL CLAMP; SKULL CLAMPS AND HEADREST SYSTEMS

Model Number A2000

Device Problem Mechanical Jam (2983)

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

Event Type  malfunction  

Event Description

A facility reported that during the final stage of an unspecified surgical procedure (during skull releasing), the mechanism on the mayfield 2000 skull clamp (a2000) was sticking/jamming, and extension blocking by plunger mechanism automatic clicking did not work properly.The procedure was successfully completed in the normal way, finally releasing the patient's skull from the faulty mayfield clamp.There was a 2-3 minutes delay without patient injury.

Manufacturer Narrative

The mayfield skull clamp (a2000) was returned for evaluation: device history record (dhr) - the manufacturing process and final device inspection (form 1101) ensures that non-conforming product is not released into the distribution chain.Failure analysis - the investigation of the returned device showed that the reported complaint was confirmed from the evaluation.The skull clamp (item no.15m0732) extension was blocking.The plunger stud was bent and must be replaced along with the plunger cap, which will fix the blocking of the ratchet extension.Two of the labels were worn off and must be replaced.Additionally, the locking of the swivel base assembly was cleaned and underwent maintenance.Root cause - the unit had a damaged plunger stud blocking the ratchet extension.Potential root cause is normal wear and tear.No further investigation is required based on the acceptability of risk and no adverse trends were identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• Brand Name: MAYFIELD 2000 SKULL CLAMP
• Type of Device: SKULL CLAMPS AND HEADREST SYSTEMS
• 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: 15563232
• MDR Text Key: 302244226
• Report Number: 3004608878-2022-00208
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253655
• UDI-Public: 10381780253655
• Combination Product (y/n): N
• PMA/PMN Number: K932807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A2000
• Device Catalogue Number: A2000
• Device Lot Number: 099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Date Manufacturer Received: 09/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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