MAUDE Adverse Event Report: TORNIER S.A.S. UNKNOWN 611 SCREW; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number UNK_WTM

Device Problems Break (1069); Fracture (1260)

Patient Problems Non-union Bone Fracture (2369); Foreign Body In Patient (2687); Implant Pain (4561)

Event Date 09/14/2022

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.Upon completion of the investigation, additional information will be provided in a supplemental report.The device remains implanted in the patient.

Event Description

It was reported that the patient underwent a nail removal due to joint fusion did not occur, persistent pain in the patient.During removal the 2 anteroposterior screws broke.Half of the screw remained in the posterior part of the calcaneus as well as in the locking hole of the nail making it very complicated to remove the nail.Lengthening of more than 2 hours the duration of the intervention.The 2 pieces of screw could not be removed and were therefore left in the patient's calcaneum.The surgeon was forced to use the sledgehammer to avoid a new posterior approach, which could have further weakened the patient's calcaneus.

• Brand Name: UNKNOWN 611 SCREW
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15584309
• MDR Text Key: 301549087
• Report Number: 3000931034-2022-00342
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_WTM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention