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

Catalog Number A2114

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device was not yet returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A customer reported that the adaptor of the a2114 mayfield infinity xr2 skull clamp that accepts the pin broke and the piece was missing.There was no known patient involvement or delay in surgery.

Manufacturer Narrative

(b)(4).The device was returned for evaluation.The reported compliant was confirmed from the evaluation.The unit was received without pedi rocker arm or suit case.The evaluation showed that the unit did not meet all specific functional test.Unit received with the internal parts to the 80# torque knob were received separated from the knob and the retaining ring is missing.The observed condition is likely caused by improperly handling of the device and the definite root cause cannot be reliably determined.The device exceeds its expected life of seven (7) years (manufactured on 2011).No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Event Description

N/a.

• Brand Name: MAYFIELD INFINITY XR2 SKULL CLAMP
• Type of Device: MAYFIELD
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• MDR Report Key: 10261119
• MDR Text Key: 198517058
• Report Number: 3004608878-2020-00360
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K130389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/11/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: A2114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 07/15/2020
• Supplement Dates FDA Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1