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

Model Number ACROBAT-I STABILIZER

Device Problem Mechanical Problem (1384)

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

Event Date 06/28/2023

Event Type  malfunction  

Manufacturer Narrative

Trackwise #: (b)(4).The investigation has been started since the complaint was received, the following contents have been conducted: dhr review: the dhr of the reported lot 3000294462 has been reviewed.No non-conformity relevant with the reported issue is 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 tightened and can also tighten the flexlink arm.Trend review: 28th jun 2022 to 28th jun 2023, the occurrence rate is approx.0.080% for suzhou manufactured om-10000/om-10000z which is under anticipated rate.Returned device evaluation: the device was received on jul.24th 2023, the following evaluations have been conducted: visual inspection: no visual defects were observed on the device; functional test: rotating the knob in clockwise, idling rotating was found, the knob cannot be tightened and flexlink arm cannot be tightened.To check this knob idling rotating during tightening, the stabilizer was disassembled for checking the relevant assembly and components status.Disassemble and examine the assembly according to the applicable manufacturing process instructions, it is found that the lead-in thread on acme nut was broken.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.Check the pilot crimping and its position, the pilot crimping is conforming to process instruction requests.Replace the abnormal acme nut with a new one taken from another raw material lot to check the function of the returned product.It¿s not found knob tighten issue, the knob rotating smoothly without idling, and the flexlink arm can be tightened.The component dimension was checked, which is conforming to the drawing requirements, no deficiency was observed.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.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 flexlink arm could not be tightened.

Event Description

On (b)(6), 2023, the hospital reported that in a case of coronary artery bypass surgery, when the stabilization system was installed, the operator found that the knob could not be tightened, after replacing with a new product, it was used normally and the operation was completed.The product is from lot 3000294462.

• Brand Name: MAQUET
• Type of Device: STABILIZER, HEART
• Manufacturer (Section D): MAQUET (SUZHOU) CO.,LTD.; no.158 fang zhou road; suzhou industrial park; suzhou
• Manufacturer (Section G): MAQUET (SUZHOU) CO.,LTD.; no.158 fang zhou road; suzhou industrial park; suzhou
• Manufacturer Contact: lu helena ; no.158 fang zhou road; suzhou industrial park; suzhou
• MDR Report Key: 17421812
• MDR Text Key: 320088937
• Report Number: 3007417753-2023-00003
• Device Sequence Number: 1
• Product Code: MWS
• 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
• Report Date: 07/31/2023

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
• Device Operator: Health Professional
• Device Model Number: ACROBAT-I STABILIZER
• Device Catalogue Number: OM-10000
• Device Lot Number: 3000294462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Initial Date Manufacturer Received: 07/15/2023
• Initial Date FDA Received: 07/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male