MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA ¿MAYFIELD COMPOSITE SERIES BASE UNIT, STANDARD¿; ¿COMPOSITE SERIES¿

Model Number	A3101
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
This is 1 of 2 reports linked to mfg report number 3004608878-2022-00206.A facility reported that mayfield composite series base unit, standard (a3101) was used for a posterior cervical fusion, and patient slippage occurred which caused laceration to the posterior lateral scalp of the patient.Staples were placed to close the laceration, and different mayfield devices were used to complete the procedure.There was less than 30 minutes delay on surgery.Additional information received indicates that it is unknown if the devices slipped or if it was due to application.Both devices that were involved in the incident are being sent back for evaluation as a precaution due to the patient injury.
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
N/a.
Additional Manufacturer Narrative
The mayfield composite series base unit (a3101) was returned for evaluation: device history record (dhr) - dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis: investigation showed that the unit was received without the a3018 swivel adapter.The unit had the transitional replaced due to having worn teeth.The handle had the roll pin replaced due to testing low when put under pressure.General maintenance and cleaning performed and worn components were replaced.Root cause: complaint not confirmed.Repairs could not duplicate slippage due to not having all parts that were involved with the set up.The unit was received without the swivel adapter.Unit required replacement of worn components from routine use and wear.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 COMPOSITE SERIES BASE UNIT, STANDARD¿
• Common Device Name: ¿COMPOSITE SERIES¿
• 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: 15562941
• Report Number: 3004608878-2022-00205
• Device Sequence Number: 6511065
• Product Code: FWZ
• UDI-Device Identifier: M248A31011
• UDI-Public: 10381780268161
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: A3101
• Device Catalogue Number: ¿A3101¿
• 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: 09/13/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2017
• 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 SKULL CLAMP (SN (B)(6))
• Patient Sex: Unknown