MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE INSPACE? IMPLANT - SMALL; SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL

Catalog Number 0127

Device Problems Filling Problem (1233); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/20/2021

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Event Description

It was reported that the procedure was not completed.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: device failed to inflate during surgery probable root cause: design - inadequate fluid pathway design (handle, needle, spacer and plug) - inadequate raw material specification - backstopper connection is poor process - handle, needle and/or spacer not manufactured to specification - incorrect material used during manufacture - inadequate sealing performed in-process - incorrect size of spacer in package - incorrect packaging causes exposure to humidity - incorrect manufacturing process causing puncture in balloon - backstopper assembly is poor application - user not familiar with device - wrong positioning of the device in-situ - user inattention or oversight to specified inflation volume - protecting sheath not completely removed - excessive force during inflation - excessive manipulation or movement of the deployer before deployment, release of back stopper prematurely - spacer contacts other devices or difficult anatomy in shoulder - incorrect device size selected - difficult anatomy - poor visualization - wrong storage conditions (high temperatures) - spacer only partially filled due to exposure of the filling holes to the subacromial space the reported failure mode will be monitored for future reoccurrence.Please note that the initial reports type of reportable event was serious injury.Per additional information received, the procedure was able to be completed successfully with a different device therefore making the event not reportable.Manufacture date is not known.H3 other text : 81.

Event Description

Please note that the initial reports type of reportable event was serious injury.Per additional information received, the procedure was able to be completed successfully with a different device therefore making the event not reportable.

• Brand Name: INSPACE? IMPLANT - SMALL
• Type of Device: SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 12557606
• MDR Text Key: 274216591
• Report Number: 0002936485-2021-00526
• Device Sequence Number: 1
• Product Code: QPQ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: DEN200039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0127
• Device Lot Number: 080221-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 63 KG