MAUDE Adverse Event Report: TORNIER INC AEQUALIS FLEX REVIVE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	ARS655200
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
Upon assembling the revive stem construct, the assembly screw, proximal body, distal stem and spacers were connected using the black handle torque limited assembly screwdriver.The locking cap was placed inside the proximal body and locked with the torque limited screwdriver.The stem was attached to the broach handle and implanted (uncemented) into the patient.When the tray was placed onto the proximal body, the morse taper did not engage.The locking cap was unscrewed then re-tightened encase this was initially cross threaded.The tray would still not engage to the proximal body.The locking cap was again removed and subsequently dropped.The surgeon asked if the locking cap was a requirement which i responded ¿yes, it prevents the assembly screw from backing out¿.The spare locking cap was opened and screwed in place.The tray still did not engage.At this point the surgeon said too much time had been wasted and was satisfied that the assembly screw was fully engaged, fully tightened and would proceed without the locking cap.The surgery was completed by implanting the tray and poly insert.Surgery was completed by not implanting a locking cap, the stem was already implanted, no back up device was available.It added an additional 30 minutes to the procedure trying to remove the cap multiple times.The patient also received additional blood.
Event or Problem Description
Upon assembling the revive stem construct, the assembly screw, proximal body, distal stem and spacers were connected using the black handle torque limited assembly screwdriver.The locking cap was placed inside the proximal body and locked with the torque limited screwdriver.The stem was attached to the broach handle and implanted (uncemented) into the patient.When the tray was placed onto the proximal body, the morse taper did not engage.The locking cap was unscrewed then re-tightened encase this was initially cross threaded.The tray would still not engage to the proximal body.The locking cap was again removed and subsequently dropped.The surgeon asked if the locking cap was a requirement which i responded ¿yes, it prevents the assembly screw from backing out¿.The spare locking cap was opened and screwed in place.The tray still did not engage.At this point the surgeon said too much time had been wasted and was satisfied that the assembly screw was fully engaged, fully tightened and would proceed without the locking cap.The surgery was completed by implanting the tray and poly insert.Surgery was completed by not implanting a locking cap, the stem was already implanted, no back up device was available.It added an additional 30 minutes to the procedure trying to remove the cap multiple times.The patient also received additional blood.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: AEQUALIS FLEX REVIVE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• MDR Report Key: 11851940
• Report Number: 3004983210-2021-00043
• Device Sequence Number: 11699022
• Product Code: KWS
• UDI-Device Identifier: 00846832069576
• UDI-Public: 00846832069576
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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 Expiration Date: 03/10/2025
• Device Model Number: ARS655200
• Device Catalogue Number: ARS655200
• Device Lot Number: AZ0519252234
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention