MAUDE Adverse Event Report: TORNIER S.A.S. FLEX SHOULDER SYSTEM REV INSERT D36 TH+6 STD ANGLE 12.5/B; SHOULDER JOINT POLYMER PROSTHESIS

Model Number	DWF361B
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional new information becomes available, it will be provided on a supplemental report.
Event or Problem Description
Towards the end of the operation, after the stem/tray assembly has been implanted into the humerus, we opened the reversed insert of the size and thickness determined during the trialing step.The surgeon placed even pressure on the insert to initially seat the insert into the tray and it immediately entered the place without the need of using the impactor handle and insert tip.The surgeon was advised to check that the connection between the tray and insert was strong enough.Using only his thumb, very easily the insert was pulled out of place.It was tried again to make an impaction but the result was similar.At the end of the operation, a new 6 plus insert was implanted in the patient's body, which is the size that matched the patient's anatomy.The surgeon did put in a 9 plus experimental implant just to see which size was more appropriate, but as mentioned chose to stick with the smaller insert.Adverse consequences were fracture in the glenoid, 2 revision surgeries since reported under stryker reference pi 2693044.

• Brand Name: FLEX SHOULDER SYSTEM REV INSERT D36 TH+6 STD ANGLE 12.5/B
• Common Device Name: SHOULDER JOINT POLYMER PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• MDR Report Key: 11862764
• Report Number: 3000931034-2021-00246
• Device Sequence Number: 19925257
• Product Code: KWS
• UDI-Device Identifier: 03700386940507
• UDI-Public: 03700386940507
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K122698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/21/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2025
• Device Model Number: DWF361B
• Device Catalogue Number: DWF361B
• Device Lot Number: AC8915
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 05/21/2021
• 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: Other