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

Model Number	0131
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Serious Injury
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.Correction: the correct fda registration number is (b)(4).
Event or Problem Description
It was reported that there was patient pain that required an additional surgery to remove the device.
Additional 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: patient pain.Probable root cause: design: inadequate raw material specification process: spacer not manufactured to specification; incorrect material used during manufacture; incorrect packaging or error in packaging process causes exposure to humidity or high temperatures.Application: use of expired product; wrong storage conditions; re-use of single-use device; use of contrast media; wrong patient or device selection; patient not following rehab procedure.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text: 81.
Event or Problem Description
It was reported that there was patient pain that required an additional surgery to remove the device.

• 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): ORTHOSPACE LTD.; 7 halamish st.; caesarea 30795 79; IS 3079579
• Manufacturer Contact: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16591959
• Report Number: 3016573902-2022-00006
• Device Sequence Number: 14686861
• 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): 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0131
• Device Catalogue Number: 0131
• Device Lot Number: 290322-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown