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 06/22/2022

Event Type  malfunction  

Event Description

The hospital reported that during a coronary artery bypass procedure using acrobat-i stabilizer, the knob cannot be tightened.This complaint belongs to om-10000.The problem was discovered during use and did not affect the patient, and the operation was completed after replacing the same product.The product is from lot 3000216540.

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 3000216540 has been reviewed.No non-conformity indicating the reported failure 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 link arm.Trend review: in the last 12 months, 22th june 2021 to 22th jun 2022, the occurrence rate is approx.0.090% for suzhou manufactured om-10000/om-10000z.There is no same failure reported for this lot# 3000216540.Returned device evaluation: the device was received on june.27th 2022, the following contents have been done: visual inspection: no visual defects were observed on the product; functional test: rotating the knob, idling rotating was found, the knob cannot be tightened and link 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 knob assembly mp-bh-0005.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 was tested 30 times according to ifu, and found that no knob tighten issue happened, the knob rotating smoothly without idling, and the link arm can be tightened.The relevant components' dimensions were checked, which 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 function 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.

• 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: 14941627
• MDR Text Key: 304462373
• Report Number: 3007417753-2022-00015
• 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: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2024
• Device Model Number: ACROBAT-I STABILIZER
• Device Catalogue Number: C-OM-10000
• Device Lot Number: 3000216540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 74 KG
• Patient Race: Asian