MAUDE Adverse Event Report: MAQUET (SUZHOU) CO.,LTD. ACROBAT-I POSITIONER CH; STABILIZER, HEART

Model Number	ACROBAT-I POSITIONER CH
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during a coronary artery bypass procedure using acrobat-i positioner ch, they turned the knob properly to fix the xp5000z arm, but the arm wasn't fixed.The knob was tightened normally and peaked (clicked), but the fixation moved loosely compared to other lot products.The surgery was successfully completed using the new xp5000z.There was no effect on the patient.
Additional Manufacturer Narrative
Trackwise id (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
Additional Manufacturer Narrative
Correct manufacturing to "wayne".
Additional Manufacturer Narrative
Trackwise #(b)(4).Updated sections: b4, g-4.G-7, h-2, h-6, h-10.The investigation including the following contents has been conducted: 1.Analysis of production: (3331, 4109): the dhr of the reported lot 3000185835 has been reviewed.No non-conformity indicating the reported failure was observed.All the products had been performed 100% mechanical function test during production.They all passed the function test, which demonstrate the knob can be tighten and also can tighten the link arm.2.Trend analysis: (4110): in the last 12 months, 02-feb 2021 to 02-feb 2022, the occurrence rate for ¿knob difficult/ unable to tighten- arm does not lock¿ is approx.(b)(4) which is under anticipated rate.3.Testing of actual/suspected device & testing of raw/starting materials: (10 & 4105) returned product evaluation: the device was received and the following evaluations have been conducted: 1) physical inspection: no visual defects were observed on the product; 2) functional test: assemble the device securely onto a reference retractor blade by sliding the positioner base onto the rail and locking the lever.Evaluate the knob for its ability to tighten the flexlink arm while the locking lever in both the locked and unlocked positions.The knob was rotating normally, the knob can be tightened and flexlink arm can be tightened.3) disassemble the device and check the assembly status according to the applicable manufacturing process instructions knob assembly mp-bh-0004.It is found that the lead-in thread on acme nut was broken.4) verify 2 to 4 threads of the acme screw are exposed past the housing mount.It shows about 3 threads out of the housing mount, the returned product is conforming to this requirement.5) check the pilot crimping and its position, the pilot crimping is conforming, without defects on it, and its position is there without moving.6) the dimension of the relevant components are measured and within drawing specification, no deficiency indicating the knob tighten and flexlink arm tighten issue was observed.There's no non-conformity observed indicating the acme nut thread broken or defect from raw material inspection.All the products had been performed 100% mechanical function test during production.They all passed the function test which demonstrate the knob can be tighten and also can tighten the link arm.7) to try to understand how was the acme nut broken, the further simulation test was performed.When rotating the knob with extreme strength pulling the flexlink arm forward from mount, the knob rotating was found stuck or idling, and knob cannot be tightened and flexlink arm cannot be tightened.Release the extension of the flexlink arm, and rotating the knob, the knob can be tightened and flexlink arm can be tightened.Replace the broken acme nut with a new one and perform the test again, it¿s found knob rotating stuck by pulling the flexlink arm forward with extreme strength, keep rotating rapidly with high strength, the knob rotating found to be idling.Dismount the knob, we can see the acme nut lead in thread broken.Pulling the flexlink arm forward would potentially make the acme nut and acme screw misaligned, if keep rotating with high strength, the acme nut lead in thread could be broken.Reviewing the mechanism of the knob tightening, it¿s indicated the knob rotating idling or stuck was caused because of the misalignment of acme nut and acme screw lead in thread, when rotating the knob by pulling the arm forward with extreme strength, or rotating anti-clockwise rapidly for several circles and then rotating the knob clockwise rapidly, or rotating the knob leaner with too much strength, the acme screw could not be well engaged or even not engaged with acme nut, then rotating become stuck or idling, which resulted in the knob could not be tightened, and link arm could not be tightened.Based upon the above evaluation, there¿s no deficiency identified from production relevant to the mechanical issue- knob difficult/ unable to tighten-arm does not lock prior to this complaint.It is not indicated that it is the product problem, and also not indicates a manufacturing defect caused or contributed to the reported failure during the investigation.The most probable root cause of the knob difficult/ unable to tighten-arm could be the misalignment of acme nut and acme screw when using with extreme strength pulling flexlink arm forward or rotating the knob rapidly or leaner with too much strength.
Event or Problem Description
N/a.

• Brand Name: ACROBAT-I POSITIONER CH
• Common Device Name: STABILIZER, HEART
• Manufacturer (Section D): MAQUET (SUZHOU) CO.,LTD.; no.158 fang zhou road; suzhou industrial park; suzhou
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; suzhou industrial park; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; suzhou industrial park; wayne, NJ
• MDR Report Key: 13598924
• Report Number: 3007417753-2022-00007
• Device Sequence Number: 17600637
• Product Code: MWS
• UDI-Device Identifier: 00607567500006
• UDI-Public: 00607567500006
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/30/2023
• Device Model Number: ACROBAT-I POSITIONER CH
• Device Catalogue Number: C-XP-5000Z
• Device Lot Number: 3000185835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2022
• Supplement Date Received by Manufacturer: 03/07/2022; 10/31/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 03/30/2022; 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male