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

Model Number 0132

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2022

Event Type  malfunction  

Event Description

It was reported that the patient had an infection that required a wash out.

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.

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 Description

It was reported that the patient had an infection that required a wash out.

• Brand Name: INSPACE US LARGE
• 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): 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
• MDR Text Key: 296505686
• Report Number: 0002936485-2022-00425
• Device Sequence Number: 1
• Product Code: QPQ
• UDI-Device Identifier: 17290013396065
• UDI-Public: 17290013396065
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN200039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/07/2022
• 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