MAUDE Adverse Event Report: ORTHOSPACE LTD. INSPACE US MEDIUM; SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATAB

Catalog Number	0131
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/29/2024
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.
Event or Problem Description
It was reported that the initial procedure had no issues and was successful at the time of insertion.At no time was there any belief the product was damaged or broken after insertion.The procedure was finished and went well.On later date, after operation, the patient fell and aggravated his shoulder.Patient had x-rays on which showed ¿a new tiny man-made density projecting between the acromion and the humeral head measuring 4 x 1 mm.¿ further x-rays on then showed ¿there is a metallic clip in the subacromial space.¿ an ultrasound also showed ¿a small amount of fluid is identified in between the acromion and head of the humerus.More inferior and deeper, along the proximal/medial humeral head there is a collection of fluid measuring 3.4 x 2.2 x 2.3 cm.¿ an additional surgery was then completed by the surgeon to remove the inspace balloon with ¿balloon removed intact without fluid with metal fragment inside it.¿ according to the surgeon, the tip of the inflation cannula broke off in the neck of the device.With the inflation cannula not visible prior to the deployment and inflation of the device, staff did not notice a difference in the cannula.
Event or Problem Description
It was reported that the initial procedure had no issues and was successful at the time of insertion.At no time was there any belief the product was damaged or broken after insertion.The procedure was finished and went well.On later date, after operation, the patient fell and aggravated his shoulder.Patient had x-rays on which showed ¿a new tiny man-made density projecting between the acromion and the humeral head measuring 4 x 1 mm.¿ further x-rays on then showed ¿there is a metallic clip in the subacromial space.¿ an ultrasound also showed ¿a small amount of fluid is identified in between the acromion and head of the humerus.More inferior and deeper, along the proximal/medial humeral head there is a collection of fluid measuring 3.4 x 2.2 x 2.3 cm.¿ an additional surgery was then completed by the surgeon to remove the inspace balloon with ¿balloon removed intact without fluid with metal fragment inside it.¿ according to the surgeon, the tip of the inflation cannula broke off in the neck of the device.With the inflation cannula not visible prior to the deployment and inflation of the device, staff did not notice a difference in the cannula.
Additional Manufacturer Narrative
Device investigation conclusions: based on the event description, communication log, visual inspection, functional testing it can be concluded that: 1) the device dhr is complete, and the device was released for commercial and clinical use according to specifications.2) the metal tube broke at the filling hole.Such breakage can occur when the user does not follow the instructions for the procedure (sealing and detaching the implant "turn it all the way"), rotating the knob less than 50% of complete rotation while applying excessive vertical force on the device which is not required in order to operate the device correctly (do not use excessive force).As a result, plugging was not fully complete, leakage of fluid had occurred and the metal tube broke this potential scenario also suggest the deployer was not inspected after use as indicated in the ifu (inspect the inspace¿ deployer parts after use to ensure they have not been damaged and that no parts have remained in the body).3) the root cause for the reported event is use error.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: INSPACE US MEDIUM
• Common Device Name: SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATAB
• 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: 19240164
• Report Number: 3016573902-2024-00003
• Device Sequence Number: 7107702
• Product Code: QPQ
• UDI-Device Identifier: 17290013396058
• UDI-Public: 17290013396058
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: DEN200039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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 Catalogue Number: 0131
• Device Lot Number: 190123-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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