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

Model Number ACROBAT-I STABILIZER

Device Problems Positioning Failure (1158); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2021

Event Type  malfunction  

Manufacturer Narrative

Trackwise id# (b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.

Event Description

The hospital reported that during a coronary artery bypass procedure using acrobat-i stabilizer.The knob cannot fix the flexible arm.Replacing the same equipment to complete the operation without harming the patient.

Manufacturer Narrative

Trackwise #(b)(4).Event description: the hospital reported that during a coronary artery bypass procedure using acrobat-i stabilizer.The knob cannot fix the flexible arm.Replacing the same equipment to complete the operation without harming the patient.No adverse events occurred during postoperative follow-up.The product is from lot 3000189482.This issue occurred in china, and it is determined to file a medical device reporting since the similar products are sold in us.The investigation has been started since the complaint was received, and the following contents has been conducted: 1.Dhr review: the dhr of the reported lot 3000189482 has been reviewed.No non-conformity indicating the reported failure was observed.All the products had been performed 100% mechanical functional test during production.They all passed the function test which demonstrate the knob can be tightened and also can tighten the link arm.2.Trend review: in the last 12 months, 28th dec 2020 to 28th dec 2021, the occurrence rate is approx.(b)(4) for suzhou manufactured om-10000/om-10000z.There¿s no complaint reported for this lot 3000189482.3.Returned product evaluation: the device was received on dec.31st 2021, the following contents have been done: 1) visual inspection: no visual defects were observed on the product; 2) functional test: rotating the knob, it can be tightened, and the link arm can be tightened.Loose the knob, and do the knob tightening again at leaner direction, it idle rotating, the knob can¿t be tightened and link arm can¿t be tightened.To check this knob idle rotating phenomenon during tightening, the stabilizer was disassembled for checking the relevant assembly and components status.3) disassemble and examine the assembly according to the applicable instructions found in the manufacturing process instructions knob assembly (b)(6).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 to process instruction requests.6) replace the abnormal acme nut with a new one taken from another raw material lot to check the function of the returned product.It was tested 30 times according to ifu, and found that no knob tighten issue happened, the knob rotating smoothly without idle rotating, and the link arm can be tightened.7) the stabilizer was furtherly disassembled to check the relevant components' dimensions, the dimensions are conforming to the drawing requirements, no deficiency was observed.It¿s indicated based on the above evaluation that, the knob idling rotation during tightening would be caused by the acme nut lead-in thread broken, since the broken thread would be potentially not smoothly engaged or even not engaged with the acme screw lead- in thread during tightening.However, no non-conformities indicating the acme nut thread broken or defect from raw material were observed.All the products have passed 100% mechanical functional test in process, which demonstrated the knob can be tightened and link arm can be tightened.Complaint historical data has also been reviewed, the failure knob difficult/ unable to tighten-arm does not lock happened before and has been investigated.The most probable root cause for the acme nut lead in thread broken would be rotating to loosen the knob anti-clockwise rapidly for several circles and then rotating to tighten the knob clockwise rapidly, or rotating the knob leaner or too much strength used, which caused acme screw misaligned with the acme nut lead-in thread, acme nut lead-in thread broken, then the knob could not be tightened and link arm could not be tightened.

Event Description

N/a.

Manufacturer Narrative

Trackwise # (b)(4).Corrected sections: d-8, h-6 problem code corrected from "1384" to "1158" updated sections: b-4, g-4, g-7, h-2, h-10, h-11.

• Brand Name: ACROBAT-I STABILIZER Z
• Type of Device: STABILIZER, HEART
• Manufacturer (Section D): MAQUET (SUZHOU) CO.,LTD.; no.158 fang zhou road; suzhou industrial park; suzhou NJ
• Manufacturer (Section G): MAQUET (SUZHOU) CO.,LTD.; no.158 fang zhou road; suzhou industrial park; suzhou NJ
• Manufacturer Contact: helena lu ; no.158 fang zhou road; suzhou industrial park; suzhou, NJ
• MDR Report Key: 13296530
• MDR Text Key: 284200967
• Report Number: 2242352-2022-00077
• Device Sequence Number: 1
• Product Code: MWS
• UDI-Device Identifier: 00607567700581
• UDI-Public: 00607567700581
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2023
• Device Model Number: ACROBAT-I STABILIZER
• Device Catalogue Number: C-OM-10000
• Device Lot Number: 3000189482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 67 KG