MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD INFINITY XR2 SKULL CLAMP

Model Number	A2114
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This is 2 of 2 reports linked to mfg report number 3004608878-2022-00143: a facility reported that during an unspecified surgery, when clamping the head, the locking screw on the mayfield swivel adapter that connects the mayfield infinity xr2 base unit (a2114) and the head mount broke.The patient's head was thus freely movable and was secured by the bedding orderly to avoid injuries.No serious consequences for the patient were observed.The event led to increased surgery time of 15 minutes.
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 infinity xr2 skull clamp (a2114) was returned for evaluation: device history record (dhr) - the dhr was reviewed, and no anomalies related to the reported failure was observed.Failure analysis - the investigation of the returned device showed that the broken screw on the swivel adapter does not pertain to the a2114 skull clamp.Evaluation found the torque screw of the skull clamp was out of specification requiring overhaul to return to specification.General maintenance and cleaning performed along with replacement of missing and damaged components.Root cause -evaluation found the torque screw of the skull clamp was out of specification requiring overhaul to return to specification, probable root cause is 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 INFINITY XR2 SKULL CLAMP
• Common Device Name: MAYFIELD
• 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: 15001918
• Report Number: 3004608878-2022-00144
• Device Sequence Number: 16614641
• Product Code: HBL
• UDI-Device Identifier: 10381780253761
• UDI-Public: 10381780253761
• Combination Product (Y/N): N
• PMA/510(K) Number: K130389
• 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): 08/26/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: A2114
• Device Catalogue Number: A2114
• Device Lot Number: XR150828
• 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: 06/24/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2015
• 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
• Patient Age: 68 YR
• Patient Sex: Male