TORNIER INC TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX22MM NON STERILE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION
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Catalog Number DWJ322 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Rash (2033)
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Event Date 03/05/2024 |
Event Type
Injury
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Event Description
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During a phone call, a case of revision surgery for a joint infection related to instrument breakage was discussed.The broken instrument, identified as a screwdriver, fractured during a reverse shoulder revision surgery.The procedure involved successfully implanting a depuy spacer.The infection was detected through a superficial rash near the incision site.Microorganisms were not identified, and it's uncertain if the patient had a pre-existing infection.No sterile implants were opened during the surgery, and no re-sterilization of the device was performed before the surgery.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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The reported event was not confirmed, since the device was not returned for evaluation and no other evidence were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Infections are often caused by a multitude of factors such as comorbidity of the patient, the trauma, the surgical intervention, and the aftercare.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
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Event Description
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During a phone call, a case of revision surgery for a joint infection related to instrument breakage was discussed.The broken instrument, identified as a screwdriver, fractured during a reverse shoulder revision surgery.The procedure involved successfully implanting a depuy spacer.The infection was detected through a superficial rash near the incision site.Microorganisms were not identified, and it's uncertain if the patient had a pre-existing infection.No sterile implants were opened during the surgery, and no re-sterilization of the device was performed before the surgery.
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Search Alerts/Recalls
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