MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS GLENOID II PIN D. 2.5MM L.200MM; SURGICAL ORTHOPEDIC INSTRUMENT

Catalog Number	DWD063
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported us the following information: "description of incident: (b)(6) years old female patient, 129kg, 168cm.During a right reverse total shoulder replacement for shoulder osteoarthritis, the guide wire broke in the patient's shoulder.A part of about 1cm remained stuck in the bone.Action taken: lengthening of the procedure, impossibility to remove the entire guide wire from the shoulder.No clinical consequences for the patient".The surgical delay was 5 minutes length.
Additional Manufacturer Narrative
Upon completion of the investigation, additional will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed.The device was returned and found to be in the condition stated in the event description.The device inspection revealed the following: -the visual inspection confirmed that the device is broken at the threaded tip level.The device is bent with tools traces at the bent portion of the device (probably due to extraction attempts).-a visual macroscopic inspection showed that the device fracture corresponded to a fracture caused by a torsional overload observed by a slight material deformation at the breakage surface.-dimensionally, a part of about 7.5mm is remained stuck in the bone.-a hardness test on the returned item indicated the material being in accordance to the values in the material specification.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by an overstress applied on the tip during use when inserting the device into the guide, drilling and fixing it into the glenoid bone.Even if the device raw material is considered as ¿implantable¿ (in normal conditions of use, there is usually no risk linked to the material itself), a risk of fragment migration within the patient cannot be excluded.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 more information is provided, the case will be reassessed.
Event or Problem Description
Customer reported us the following information: "description of incident: 71 years old female patient, 129kg, 168cm.During a right reverse total shoulder replacement for shoulder osteoarthritis, the guide wire broke in the patient's shoulder.A part of about 1cm remained stuck in the bone.Action taken: lengthening of the procedure, impossibility to remove the entire guide wire from the shoulder.No clinical consequences for the patient".The surgical delay was 5 minutes length.

• Brand Name: AEQUALIS GLENOID II PIN D. 2.5MM L.200MM
• Common Device Name: SURGICAL ORTHOPEDIC INSTRUMENT
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): 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 ; 476613500
• MDR Report Key: 12738400
• Report Number: 3000931034-2021-00332
• Device Sequence Number: 5155721
• Product Code: HWE
• UDI-Device Identifier: 03700386931796
• UDI-Public: 03700386931796
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2022

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: 05/18/2026
• Device Catalogue Number: DWD063
• Device Lot Number: 0479AW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2021
• 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
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 129 KG