MAUDE Adverse Event Report: CAREFUSION, INC ASSY SPETZLER SKULL CLAMP; HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)

Catalog Number M-1500

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4) initial emdr.Device is expected to be returned for evaluation.Once the results of the investigation have been provided a follow up emdr will be submitted.

Event Description

The lock failed on the head clamp.It failed during use and the patient had to be pinned 3 times before the head clamp worked.There was no medical intervention reported.

Manufacturer Narrative

Pr 1732165 supplement emdr.One assy spetzler skull clamp was returned for investigation.The sample appeared to be new on most of the surfaces but also displayed light signs of possible usage, such as light discoloration, on the functional areas of the samples.The wear, usage marks and discoloration were superficial and contained to the surfaces only.The sample¿s failure mode was not affected by it.All parts comprising the m-1500 were returned, no missing or extra parts were noted.The ratcheting arm displayed some minor wear as expected due to regular use and ratcheting, and was found to be functioning normally.No signs of extreme wear, excessive damages, and heavy forces were noted during initial observations.It was reported that there were threading problems in the event description.Furthermore, there were markings on the device indicated with black writing ¿stripped¿ on the surface itself, next to the point of failure.Therefore, the sample was further examined at this point and tested for functionality.First, the threads of all outer six receptacles surrounded by starburst grooves on both sides of the m-1500 sample were examined.All surfaces appeared to be normal, except for one.A closer look at the middle/center threads, on one side, revealed severe thread damage, rough interruptions and occluded threads, which affected most of the threads from the start to down the receptacle.Further observations were performed by threading the mating part into each of the six starburst receptacles.The mating screw fully screwed into all, except the damaged threads.Five of the six were noted to function and mate/thread normally.The affected/damaged threads felt rough upon initial screw-in action and began to jam up approximately 1/8 of the way in.This threaded receptacle was significantly damaged and occluded with metal shavings from the previous mating screw used.The interior hole of the affected threaded receptacle was examined at 3 times magnifications.The first, third and fourth threads were deformed, flattened, discolored, and occluded by other metallic material, likely from the mating screw.Given that the sample was likely used and the cause of threading failure to be due to breaking off of another metal thread and lodging itself in the sample¿s threads.It is most likely that the issue occurred due to cross-threading during usage with a mating-part.The observed failure was likely caused upon use by end-user and clearly not caused due manufacturing error and/or personnel error.Additionally, a small pick was used to examine the large metallic occlusions in the threads, and small metal shavings of the occlusion were able to be picked out and fell out, yet most of the shavings remained lodged in the female threads of the receptacle.These observations are further evident that a cross-threading failure occurred with a mating part during usage.For further verification of the other functions on the sample.The ratcheting arm and mechanism functioned normally across the arm¿s rack length.The arm with the swiveling rocker assembly and the locking mechanism were evaluated, the arm with the two skull pin receptacles, and the knob rotated as expected, locking, unlocking, and swiveling rocker assembly of the sample.The pressure gauge knob screwed in/out completely as normal.The swiveling rocker arm and pressure gauge pin receptacles were confirmed to accept v.Mueller adult skull pins as normal.No other issues or non-conformances were noted on the returned sample.The failed threading observed can be repaired/replaced, the threads placed in the receptacle and can be removed if failed and replaced by an authorized repair facility.A replacement device will be issued.

Event Description

The lock failed on the head clamp.It failed during use and the patient had to be pinned 3 times before the head clamp worked.There was no medical intervention reported.

• Brand Name: ASSY SPETZLER SKULL CLAMP
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 10424857
• MDR Text Key: 203482015
• Report Number: 1423507-2020-00028
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• PMA/PMN Number: K002276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: M-1500
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other