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

Catalog Number UNK_ENO

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 10/26/2022

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.Correction: the correct fda registration number is (b)(4).

Event Description

It was reported that the patient had a local tissue response that led to a wash out.Please note it is unconfirmed what caused the response in the patient.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: 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 (high temperatures or exposure to humidity <40%).Re-use of single-use device.Use of contrast media.Wrong patient or device selection.Patient not following rehab procedure.Manufacture date is not known.H3 other text: 81.

Event Description

It was reported that the patient had a local tissue response that led to a wash out.Please note it is unconfirmed what caused the response in the patient.

• Brand Name: UNKNOWN_ORTHOSPACE_PRODUCT
• 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: 16590692
• MDR Text Key: 311758629
• Report Number: 3016573902-2022-00005
• Device Sequence Number: 1
• Product Code: QPQ
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_ENO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2022
• 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
• Patient Age: 67 YR
• Patient Sex: Female