MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD MODIFIED SKULL CLAMP; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Catalog Number A1059

Device Problem Device Slipped (1584)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/24/2024

Event Type  Injury  

Event Description

This is 1 of 2 reports linked to mfg report no 3004608878-2024-00019: a facility reported that slippage occurred during a procedure, resulting in minor to moderate patient harm during use of the mayfield modified skull clamp (a1059).The staff assisted in turning the patient to the prone position onto the operative table, and upon adjusting the head clamp to the desired position, staff noticed the clamps shifting and not adequately locking.Head pins and clamp was repositioned and applied; however, the positioning was still not optimal.Bleeding from pin sites occurred and original pin sites were stapled closed.A replacement headrest was used and the mayfield pins, base and clamp were quarantined.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Customer returned a1083 mayfield skull pins associated with this complaint event.As a result, see revised "failure analysis" narrative which supersedes previous narrative submitted in follow up mdr# 1: failure analysis - the investigation found no device deficiencies that would have contributed to the reported complaint, and the ¿slippage" could not be duplicated.The ratchet extension moves smoothly through the base casting, and the 80lb torque knob transitions through the ratchet extension smoothly and passes testing on the force gage.The lock has slight rotational and lateral movement, but when the clamp is properly set and put under pressure, it would not have moved.The unit was last serviced in (b)(6) 2021.It is recommended that the unit be serviced as a precaution.The roundhead screw, adjustment screw, label, screw, nut, washers, o-ring, ball bearings and wave springs were replaced, and general cleaning and maintenance were performed.Further, since an injury has been reported, the unit was sent to quality engineering (qe) for further investigation, and qe confirmed the findings of the initial investigation, noting that the only issue is slight movement in the lock.Subsequently, three a1083 mayfield disposable adult skull pins which are associated with this complaint event were returned for evaluation.Inspection of the returned pins noted that one of the pins had a very slightly bent tip.Otherwise, no issues were noted with the skull pins.They were able to securely be inserted into an a1059 skull clamp.Evaluation found no device deficiencies with these a1083 pins that would have contributed to the reported complaint.

Manufacturer Narrative

Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10.The mayfield modified skull clamp (a1059) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the investigation found no device deficiencies that would have contributed to the reported complaint, and "slippage" could not be duplicated.The ratchet extension moves smoothly through the base casting, and the 80lb torque knob transitions through the ratchet extension smoothly and passes testing on the force gage.The lock has slight rotational and lateral movement, but when the clamp is properly set and put under pressure, it would not have moved.The unit was last serviced in february 2021.It is recommended that the unit be serviced as a precaution.The roundhead screw, adjustment screw, label, screw, nut, washers, o-ring, ball bearings and wave springs were replaced and general cleaning and maintenance were performed.Further, since an injury has been reported, the unit was sent to quality engineering (qe) for further investigation, and qe confirmed the findings of the initial investigation, noting that the only issue is slight movement in the lock.Root cause - evaluation found no device deficiencies that would have contributed to the reported complaint.The probable root cause of the reported complaint is improper or suboptimal positioning of the patient in the skull clamp.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 Description

N/a.

• Brand Name: MAYFIELD MODIFIED SKULL CLAMP
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• 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: 18727975
• MDR Text Key: 335708781
• Report Number: 3004608878-2024-00018
• Device Sequence Number: 1
• Product Code: HBL
• UDI-Device Identifier: 10381780253457
• UDI-Public: 10381780253457
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A1059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2019
• 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