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

Catalog Number M-1500

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Separation Problem (4043)

Patient Problem Insufficient Information (4580)

Event Date 02/18/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial emdr.There was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this event but without a sample no corrective actions could be identified.A review of the device history record could not be performed as the lot number was unknown.If any additional information is received a supplemental emdr will be submitted with those details.Address, city: were labeled as unknown as no reporter information was provided.State was selected as (b)(6) since that was the origin of the report and the reporter's state was unknown.Zip code was selected as (b)(6) as the customer's zip code was unknown.The zip code of the reporting office was used.Date of event was unknown so bd awareness date was selected instead.

Event Description

It was reported that the instrument became unlocked and caused harm to the patient.

Manufacturer Narrative

(b)(4) supplemental emdr.Investigation findings: a m-1500 assy spetzler skull clamp was returned for manufacturing evaluation.The etchings on the sample were noted to be authentic v.Mueller and legible, with the lot code on the sample identified as k16.This lot code would indicate that this device was manufactured in november of 2016.The sample appeared to have been used, worn with scratches, nicks, dings, dents, discoloration and residues.Overall, the sample appeared to be worn and used particularly near the working areas and connection points.The wear, usage marks, and discoloration were superficial and contained to the surfaces only, the sample¿s functionality did not appear to be affected.No signs of extreme wear, excessive damage, and heavy forces were noted during initial observations.It was indicated the device was failing from a possible functional locking/unlocking issue.Upon initial functional testing the failure mode was confirmed.It was noted that the male assembly and the female assembly were returned separated.Additionally, the pawl and pawl knob assembly were disassembled and returned loose in packaging and the pawl spring was noted to be missing off the pawl part.This spring part comes apart/loose upon disassembly, however, it was not noted in the packaging and assumed to be missing or not returned.The sample was determined to be non-functional as these parts cannot be assembled back together easily.Due to the disassembly of the pawl/pawl knob the male part of the skull clamp cannot ratchet back and forth and cannot lock in place as intended.The sample was further examined in detail and tested for functionality.First, the threads on each of the outer six receptacles surrounded by starburst grooves on both sides of the m-1500 sample were examined.Each receptacle appeared to be normal upon 2 times magnified inspections, and at the middle/center threads no thread damage was observed.Further verifications were performed by threading the mating part into each of the six starburst receptacles.The mating screw fully screwed into all, and mated/threaded normally.Second, the arm with the swiveling rocker assembly and its locking mechanism was evaluated (the arm with the two skull pin receptacles) and the knob rotated as expected, locking, unlocking, and swiveling rocker assembly of the sample.Third, the pressure gage 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 only identifiable failure mode was further investigated for cause of disassembly and failure.It was noted that the pawl knob could not screw on/off easily as the threads appeared to be stripped/damaged.In addition, the pawl knob displayed clamp teeth marks around the circumference edges appearing as if they were forcibly unscrewed or removed.The set screw on the side was noted to be tightened in and secured properly, however, the set screw displayed signs of tampering nicks and dings possibly by end user.This set screw was applied on the side of the pawl knob with primer and loctite glue.It was screwed in perpendicular/lateral to the pawl knob post threads and once set screw was screwed in tight, it butted up tight against the post threads and by mechanical action secured the pawl knob in place preventing it from backing out of the threads over time.Additionally, the loctite glue prevented the set screw from backing out.It was obvious the set screw was in the correct position due to the stripped /damaged threads, possibly due to the knob being unscrewed by force while the set screw was butted up against the threads.Additionally, light residues of loctite adhesive were noted under uv light.Based on the evidence so far, the sample appeared to have been manufactured correctly.Additionally, it should be noted that the sample appeared to be used for over 5 years, possibly without issue until recently.No other issues or failures were noted on the sample, the sample¿s other functions and components performed normally.E: address, city :were labeled as unknown as no reporter information was provided.E: state was selected as illinois since that was the origin of the report and the reporter's state was unknown.E: zip code was selected as (b)(6) as the customer's zip code was unknown.The zip code of the reporting office was used.B: date of event was unknown so bd awareness date was selected instead.

Event Description

It was reported that the instrument became unlocked and caused harm to the patient.Upon further examination a superficial head laceration was found on the right lateral side of the patient's head.It was repaired with staples.

• Brand Name: SPETZLER HEADREST SYSTEM
• Type of Device: HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• Manufacturer (Section G): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 13696070
• MDR Text Key: 287120818
• Report Number: 1423507-2022-00004
• Device Sequence Number: 1
• Product Code: HBL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M-1500
• Device Lot Number: K16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other