MAUDE Adverse Event Report: AESCULAP AG COOLEY STERNOTOMY SPREADERADULT32X50MM; CARDIO-THORACIC SURGERY

Model Number FB850R

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with cooley sternotomy spreader.According to the customer description the retractor not easily cranking (turning) open once in place to retract.Aesculap repair tech worked on these to try and resolve issue; surgeon continued to complain and then refused to use them.There was no patient harm.The malfunction occurred during an open-heart procedure.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00337 (400477710 fb850r).

Manufacturer Narrative

Associated medwatch-reports: 9610612-2020-00336 (400477711 - fb850r).9610612-2020-00337 (400477710 - fb850r).9610612-2020-00733 (400489058 - fb850r).The friction marks found at the crank handles as well as on the drill holes were most likely caused be an insufficient maintenance of the devices.To avoid metal seizure and friction marks, the instructions for use must be observed.According to the 8d report no capa is necessary.

Event Description

Update: the sales representative reported that there is a handle on the device that cranks the spreader open to expand the patient's rib cage open during the procedure and that handle was getting stuck and was requiring too much effort to open the device.The device was having difficulty as there was resistance in the retractor.Despite to effort needed to open it the device did perform its intended function.There was no harm to the patient and no significant delay other than the time required to expel additional effort to get the device to retract.Only one of the device did not perform as expected in a procedure.As the other devices were exhibiting the malfunction during testing the hospital account returned them all for investigation.

Manufacturer Narrative

Updated b5: additional device was reported and mentioned as associated medwatch report.Preliminary investigation results: the device was not yet provided for investigation.Therefore a investigation of the device itself was not possible.Due to the fact that no lot number was provided til date of investigation, a review of the device history records for the complained devices was not possible to that date.The lot numbers were available till date of this report and will be checked.Information will be reported in a supplemental report.Based on the provided information and without a product for investigation, a clear conclusion can not be drawn.Based on the investigations and results of the 8d report no capa is necessary.

Event Description

Associated medwatch-reports: 9610612-2020-00336 ((b)(4) - fb850r), 9610612-2020-00337 ((b)(4) - fb850r) & 9610612-2020-00733 ((b)(4) - fb850r).

• Brand Name: COOLEY STERNOTOMY SPREADERADULT32X50MM
• Type of Device: CARDIO-THORACIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10346929
• MDR Text Key: 203130359
• Report Number: 9610612-2020-00336
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FB850R
• Device Catalogue Number: FB850R
• Device Lot Number: 52205242
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1