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

Catalog Number	0131
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after inserting the recommended amount of saline into a size medium inspace balloon, it was noticed that the metal tip of the inserter had broken off into the balloon.The balloon was then removed and another balloon was inserted it was also a size medium.
Additional 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 or Problem Description
It was reported that after inserting the recommended amount of saline into a size medium inspace balloon, it was noticed that the metal tip of the inserter had broken off into the balloon.The balloon was then removed and another balloon was inserted it was also a size medium.
Additional Manufacturer Narrative
The device was discarded and not returned for investigation.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: deployer fragmentation probable root cause: application - excessive force during insertion or positioning - incorrect size selection - premature release of back stopper - incision too small - poor visualization - difficult anatomy - wrong patient selection.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: INSPACE US MEDIUM
• Common Device Name: 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 23516135
• Report Number: 3016573902-2025-00005
• Device Sequence Number: 10097536
• Product Code: QPQ
• UDI-Device Identifier: 17290013396058
• UDI-Public: 17290013396058
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: DEN200039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0131
• Device Lot Number: 080425-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown