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

Model Number	0132
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had an infection that required a wash out.
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.
Additional Manufacturer Narrative
The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: infection.Probable root cause: design.Wrong raw material or manufacturing agent selected in-process cleaning not effective at removing manufacturing residuals not enough strict controls placed on raw material source and purity.Process: sterilization fault - including eto residuals.Contamination during manufacturing process; including endotoxins in-process cleaning not performed to spec (i.E.Residues and leachable dcm, ethanol and acetone).Application: contamination of instruments.Patient reaction/allergy sensitivity or with active/latent infection.Use of contrast media.Use of more than one implant within the shoulder.Wrong patient selection.The device manufacture date is not known.The reported failure mode will be monitored for future reoccurrence.Correction: the incorrect fda registration number was used during the initial report.The correct fda registration number is (b)(4).H3 other text: 81.
Event or Problem Description
It was reported that the patient had an infection that required a wash out.

• Brand Name: INSPACE US LARGE
• 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: 15095154
• Report Number: 0002936485-2022-00425
• Device Sequence Number: 5234264
• Product Code: QPQ
• UDI-Device Identifier: 17290013396065
• UDI-Public: 17290013396065
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 10/27/2022

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: 0132
• Device Catalogue Number: 0132
• Device Lot Number: 020621-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 10/27/2022
• 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