MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD BALL SOCKET SWIVEL ADAPTOR; SKULL PINS

Catalog Number	A1064
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
This report is 3 of 3 linked to mfg report numbers: 3004608878-2024-00039, 3004608878-2024-00040.A facility reported that there was an issue (movement) with the mayfield ball socket swivel adaptor (a1064) during craniotomy surgery.The patient was already under anesthesia when the dysfunction was observed; however, there was no consequences/impact for the patient.The surgery was finalized using a replacement unit with approximately 5 to 10 minutes increased surgery time (time to find another skull clamp).The only biographic information received is that the patient was an adult.
Additional Manufacturer Narrative
The mayfield ball socket swivel adaptor (a1064) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the inspection of the ball swivel adaptor showed that the ball joint cannot be rotated smoothly.The swivel ball holder was disassembled, and there was residue build-up inside of the assembly.The assembly required cleaning, some small internal parts must be replaced preventively, and the retaining rings and the nylon washers which hold both torque screws needed to be replaced.To resolve all issues, the assembly was cleaned and some small parts like washers and retaining rings were replaced.The ball joint can now move freely, and a successful function test was completed on the unit.Root cause - the complaint is confirmed via inspection of the unit.The assembly required cleaning and replacement of worn internal parts.Probable root cause is routine use and wear.Additionally, improper, or suboptimal placement of the skull clamp can contribute to slippage/movement of the patient.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.

• Brand Name: MAYFIELD BALL SOCKET SWIVEL ADAPTOR
• Common Device Name: SKULL PINS
• 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 08540 ; 6099362319
• MDR Report Key: 18994946
• Report Number: 3004608878-2024-00041
• Device Sequence Number: 11512396
• Product Code: FWZ
• UDI-Device Identifier: 10381780267591
• UDI-Public: 10381780267591
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: A1064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: A1059 MAYFIELD MODIFIED SKULL CLAMP.; A2101 MAYFIELD ULTRA BASE UNIT.
• Patient Sex: Unknown