MAUDE Adverse Event Report: ORTHOSPACE LTD. INSPACE IMPLANT - LARGE; SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL

Catalog Number 0129

Device Problem Expiration Date Error (2528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2023

Event Type  malfunction  

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 Description

It was reported that an expired product was used.

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: expired product.Probable root cause: design.- inadequate shelf life for product.Application.- failure to verify expiration status of product prior to surgery.The reported failure mode will be monitored for future reoccurrence.Additional investigation was conducted on this event.From the further investigation conducted it revealed that that the failure was attributed to a usage error, specifically the oversight of checking the expiration date by both the surgeon and the operating nurse.Also the hospital warehouse staff and the sales representative that are responsible for managing the consignment inventory failed to detect the expired device on time, prior to the distribution to the or and the failure detected only after the device was used.The local sales representatives are trained and instructed on how to manage consignment inventory and intended to mitigate the risk of having an expired in consignment inventory.The following actions were taken in response to the incident: - a thorough inventory check was conducted in the hospital warehouse to ensure there are no additional expired devices on stock - the sales representative received training on the relevant procedure.- a training to the surgeon and the operating room team, emphasizing the importance of verifying the device's expiration date before use was made by the hospital¿s hr.- a conversation with warehouse personnel was made by the sales representative to emphasize the significance of maintaining strict control over stock to prevent similar occurrences in the future.It is crucial to note that this event represents an isolated occurrence since the device's market introduction.Furthermore, a follow-up examination of the patient's post-operative condition, conducted more than five months after surgery, confirmed the patient's well-being without any issues.Consequently, apart from the implemented local measures, no further actions are deemed necessary.Manufacture date is not known.H3 other text : 81.

Event Description

It was reported that an expired product was used.

• Brand Name: INSPACE IMPLANT - LARGE
• Type of Device: SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL
• Manufacturer (Section D): ORTHOSPACE LTD.; 7 halamish st.; caesarea 30795 79; IS 3079579
• Manufacturer (Section G): ORTHOSPACE LTD.; 7 halamish st.; caesarea 30795 79; IS 3079579
• Manufacturer Contact: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 17225029
• MDR Text Key: 318348448
• Report Number: 3016573902-2023-00003
• Device Sequence Number: 1
• Product Code: QPQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: DEN200039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0129
• Device Lot Number: 090620-07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2023
• 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