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

Catalog Number	A1018
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
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 is 2 of 2 reports linked to mfg report number 3004608878-2025-00107: a facility reported that the mayfield swivel adaptor (a1018) was used in a case, and the joint could not hold.As a result, the device was changed.There was no patient injury; however, there was significant increased surgical time.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The mayfield swivel adaptor (a1018) was not returned after three good faith efforts (gfes) attempts were made; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The definite root cause cannot be identified as the device was not returned.However, based on the reported complaint, the probable root cause is routine wear or damage to the unit from misuse.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.The mayfield swivel adaptor (a1018) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the reported complaint is confirmed from the evaluation.The swivel adapter (sn:(b)(6)) needs to get overhauled, the starburst teeth are in good shape, the retainer rings and washers will be replaced, and the serial label and label are damaged.To resolve all issues, the swivel adapter¿s nylon washers and the retaining rings were replaced, and the unit was reassembled.The functional test was carried out successfully and the device meets manufacturer specifications.Root cause - the complaint is confirmed via inspection of the unit.The unit required overhauling and replacement of damaged and worn components.The probable root cause is rough handling and routine wear of the unit.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.

• Brand Name: MAYFIELD SWIVEL ADAPTOR
• Common Device Name: SKULL PINS
• 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: 22060423
• Report Number: 3004608878-2025-00108
• Device Sequence Number: 18095922
• Product Code: FWZ
• UDI-Device Identifier: 10381780267515
• UDI-Public: 10381780267515
• 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,Followup
• Report Date (Section B): 09/05/2025

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: A1018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 06/30/2025; 08/14/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/25/2025; 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2022
• 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: A2101 MAYFIELD ULTRA BASE UNIT.
• Patient Sex: Unknown