MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN BACTIGUARD TRANSVERSE PROXIMAL SCREW; N/A

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  

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# (b)(4).G2: foreign: germany multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2023-02597; 0001822565-2023-02598; 0001822565-2023-02600; 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.H3 other text : see h10 narrative.

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.

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.

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 distal screw 25mm: 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h10.The following sections have been corrected: d1; d2; d4; g4.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.

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.

• Brand Name: UNKNOWN BACTIGUARD TRANSVERSE PROXIMAL SCREW
• Type of Device: N/A
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17785744
• MDR Text Key: 323891666
• Report Number: 0001822565-2023-02599
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2024
• 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
• Treatment: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 89 KG