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.

Manufacturer Narrative

Please note the corrections made in the h6 method code, results code, and conclusion: the reported event could be confirmed, since x-ray provided show the breakage of the screws.A device inspection was not possible since the affected device was not returned.Since data and x-rays were provided, the opinion of the medical expert was requested and stated as following: the fact that the surgeon has used the 611 afn in a static locking mode could have attribut-ed to the non-union event.The fact that it is painful may refer to the (micro)motion that is occurring at the non-union site.The foot skeleton (talus and calcaneus) is moving slightly relative to the distal nail, as can be seen by the ¿impression¿ that the distal nail has made at its distal part.One of the option the surgeon would have had is to take the proximal screws out to dynam-ize the construct to generate compression at the fusion site to promote healing.It would be interesting to know how long the 611 afn has been in and if the patient was weight-bearing this side.The static fixation of the 611 afn together with the non-union will generate high stresses on the screws in particular.As in any other osteosynthesis relying on screw, they will eventually break if the bones do not unite.Most likely the screws were already damaged and were ei-ther broken already or did break easily during removal.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by a static locking mode option use for this patient.A review of the device history was not possible because the lot number was not communicated.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.

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: 15584310
• MDR Text Key: 301549050
• Report Number: 3000931034-2022-00341
• 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,Followup
• Report Date: 01/03/2023

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
• 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
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 12/08/2022
• Supplement Dates FDA Received: 01/03/2023
• 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