MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ACROBAT-I STABILIZER Z; STABILIZER, HEART

Model Number ACROBAT-I STABILIZER Z

Device Problems Mechanical Problem (1384); Positioning Problem (3009)

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

Event Date 08/26/2021

Event Type  malfunction  

Event Description

The hospital reported that during a coronary artery bypass procedure acrobat-i stabilizer z would not tighten down, kept spinning.A new om10000z was used to complete the case.No adverse effects to the patient, no harm, no delay to case.

Manufacturer Narrative

(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.

Manufacturer Narrative

Trackwise #(b)(4).Corrected sections: b-5, h-6 medical device ¿ problem code from "3009" to "1384" updated sections: g-4.G-7, h-2, h-6, h-10, h-11.The investigation has been started since the complaint was received, and the following contents has been conducted: analysis of production: (3331/213 & 67) : the dhr of the reported lot 3000158398 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 functional test, which demonstrate the knob can be tightened and also can tighten the link arm.Trend analysis: (4110/213 & 67) in the last 12 months, (b)(6) 2020 to (b)(6) 2021, the occurrence rate is approx.0.045% for suzhou manufactured om-10000/om-10000z.No similar complaint was reported for this lot 3000158398.Historical data analysis: (4109/213 & 67) the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Testing of actual/suspected device & testing of raw/starting materials (10 & 4105/114, 22 & 61) : 3.Returned product evaluation: the device was received on dec.16th 2021, the following tests have been conducted: 1) visual inspection: no visual defects were observed on the product; 2) functional test: rotating the knob, knob shows idling spinning, the knob cannot be tightened and link arm cannot be tightened.3) disassemble and examine the assembly according to the applicable instructions found in the manufacturing process instructions knob assembly mp-bh-0005.It is found that the lead in thread on acme nut was broken to pieces.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) replace with the acme nut from inline normal lot to conduct simulation use to check the function of the returned product.Test 30 times according to ifu, assemble the device securely onto a reference retractor blade by sliding the stabilizer 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.There¿s no knob tighten issue happened, the knob rotating smoothly without idle rotating, and the link arm can be tightened.7) the stabilizer was further disassembled to check the relevant components' dimensions, the dimensions are conforming to the drawing requirements, there's no deficiency indicating the reported failure observed.Based upon the above evaluation, the knob idle rotation would be caused by the acme nut lead in thread broken, since the broken lead in thread would potential not smoothly engage or even not engage with the acme screw lead in thread during tightening.However, there's no deficiency indicating the acme nut thread broken or defect observed from raw material inspection.All the products had been performed 100% mechanical function test and passed during production.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 was investigated.The most probable root cause for the acme nut lead in thread broken would be that rotating to lose 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.Communication/interviews: (4111/213 & 67) communication/interviews were performed to obtain all possible information.

Event Description

The hospital reported that during a coronary artery bypass procedure acrobat-i stabilizer z would not tighten down, kept spinning.A new device was opened to complete the case.No adverse effects.

• Brand Name: ACROBAT-I STABILIZER Z
• Type of Device: STABILIZER, HEART
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 12956727
• MDR Text Key: 283153613
• Report Number: 2242352-2021-01023
• Device Sequence Number: 1
• Product Code: MWS
• UDI-Device Identifier: 00607567100008
• UDI-Public: 00607567100008
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2023
• Device Model Number: ACROBAT-I STABILIZER Z
• Device Catalogue Number: OM-10000Z
• Device Lot Number: 3000158398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1