Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 05/23/2023 |
Event Type
Injury
|
Event Description
|
It was reported that a patient underwent a tibial bone fracture fixation procedure.Approximately seven (7) weeks post-implantation, the patient underwent a nail dynamization procedure for unknown reasons.The proximal screw of the intramedullary nail was removed.Due diligence is in progress for this event; to date no further information has been reported.
|
|
Manufacturer Narrative
|
(b)(4), a2: year of birth: 1989.D10: medical product: tibial nail - yellow 8.3 mm diameter 30 cm length: catalog#47249530008, lot#ni; unknown cortical screw: catalog # ni, lot # ni, qty # 4.G2: foreign: germany.Multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2023-02597; 0001822565-2023-02598; 0001822565-2023-02599; 0001822565-2023-02601; 0001822565-2023-02602.It was reported that a total of five (5) distal and proximal cortical screws were implanted, and one (1) was removed.At the time of this report, it is unknown which screw was removed during the additional surgery.The product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.D10: medical product: tibial nail - yellow 8.3 mm diameter 30 cm length: catalog#: 47249530008, lot#: ni; unknown proximal screw - dynamization slot: catalog#: ni, lot#: ni; unknown transverse proximal screw: catalog#: ni, lot#: ni; unknown distal screw 15mm: catalog#: ni, lot#: ni; unknown distal screw 5mm: catalog#: ni, lot#: ni.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
It was reported that a patient underwent a tibial bone fracture fixation procedure following involvement in a motor vehicle accident.Approximately seven (7) weeks post-implantation, the patient underwent a nail dynamization procedure for unknown reasons.The proximal screw of the intramedullary nail was removed.Due diligence is complete as multiple attempts have been made however no further information has been reported.
|
|
Event Description
|
Additional information has updated the product information that was previously reported.The updated product information reflects a product line that does not have fda clearance and is not distributed in the united states.The initial and supplemental reports for this device were filed in error.A corrected report has been submitted to the appropriate notified body.
|
|
Manufacturer Narrative
|
D2, g4: as the device is not registered with the fda, product code and 510k are not applicable.Additional information has corrected the product information that was previously reported.The correct product information reflects a product line that does not have fda clearance and is not distributed in the united states.The initial and supplemental reports for this device were filed in error.A corrected report has been submitted to the appropriate notified body.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Search Alerts/Recalls
|