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

Catalog Number A2114

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 12/17/2018

Event Type  Injury  

Manufacturer Narrative

The device has not yet been 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 sales representative reported on behalf of the customer that on (b)(6) 2018, after the patient was pinned, the 439a1010 adult rocker arm of the a2114 mayfield infinity xr2 skull clamp broke.The patient's head fell against the xr2 ratchet arm extension and caused minimal injury.An unspecified medical intervention was required with a 60-minute delay of surgery.Additional information has been requested to the customer.

Manufacturer Narrative

The returned unit did not meet all specific functional test.The unit was received with the stem broken off the rocker arm.It also did not have the k,pedi rocker arm or suit case; the device history record reviewed with no abnormalities related to the reported failure.The devices manufactured during this period passed all required inspection points with no associated mrr¿s, variances or rework.The reported event was confirmed.The underlying root cause for the reported event is unknown, however, during evaluation was observed the unit received with the stem broken off of the rocker arm, possible caused by normal wear.

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: 8225778
• MDR Text Key: 132339509
• Report Number: 3004608878-2019-00002
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K090506
• 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: 12/17/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: A2114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 01/31/2019
• Supplement Dates FDA Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 439A1010 ADULT ROCKER ARM; 439A1010 ADULT ROCKER ARM