MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED SCREW; SHOULDER JOINT METAL PROSTHESIS

Model Number	MULTIDIRECTIONAL LOCKING SCREW D4,5MMXL32MM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
4th and final screw, second of the multidirectional, being inserted on screwdriver during a reverse shoulder arthroplasty sheared once the thread had engaged with the ring inside the baseplate.Another screw was available of the same size, but the surgeon had concern with removing the threaded screw and was satisfied with fixation so left in situ.Surgeon did mention the patient had sclerotic bone and the glenoid was unusually hard, furthering his concern about removing and reinserting another screw.
Additional Manufacturer Narrative
On november 10th, 2020 stryker trauma and extremities acquired tornier sas.An effort was made to align the acquired entity complaint files with stryker's policies and procedures.Stryker has performed retrospective review of complaints and the reportability decision was revised to report this incident under the mdr process.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Based on data given, patient had sclerotic bone and the glenoid was unusually hard.Based on previous analysis, screw breakage under head in per-operative can be related to several reasons: in case of a motorized screwdriver use which may generate an excessive torque.In screwing on a relatively dense bone in link with the screw length.In case of a bad hexagonal gripping/fitting between the screw and the screwdriver.In this case, the second hypothesis seems to be the most likely since the patient had unusual hard bone.According to the data available, the root cause is not related to the device but rather to the patient condition (hard bone).

• Brand Name: AEQUALIS REVERSED SCREW
• Common Device Name: SHOULDER JOINT METAL PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• Manufacturer Contact: janice mithouard ; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 13606775
• Report Number: 3000931034-2022-00083
• Device Sequence Number: 12248909
• Product Code: KWS
• UDI-Device Identifier: 03700386917103
• UDI-Public: 03700386917103
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K050316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2022
• Device Model Number: MULTIDIRECTIONAL LOCKING SCREW D4,5MMXL32MM
• Device Catalogue Number: DWD132
• Device Lot Number: 3888AS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2017
• 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