MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ZNN PROXIMAL LOCKING SCREW; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported via a clinical study that a patient underwent a bone fixation procedure.On an unknown time frame post-implantation, the patient presented with motion pain.Subsequently, the patient underwent additional surgery to fix the implanted tibial nail and screws.Due diligence is in progress for this event; to date no additional information has been provided.

Manufacturer Narrative

(b)(4).Event occurred in 2012 though exact date is unknown.Implantation occurred in 2012 though exact date is unknown.Report source: foreign: germany.Medical product: tibial nail - yellow 9.3 mm diameter 38 cm length: catalog#47249538009, lot#ni; unknown zimmer natural nail screw: catalog#ni, lot#ni, qty#6.Multiple mdr reports have been filed for this event.Please see associated reports: 0001822565-2022-02901; 0001822565-2022-02902; 0001822565-2022-02903; 0001822565-2022-02905; 0001822565-2022-02906; 0001822565-2022-02907; 0001822565-2022-02908.Customer has indicated that the product will not be returned to zimmer biomet for evaluation, as it was requested but not returned by the hospital.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: visual and dimensional evaluations of the product could not be performed as no product was returned nor were pictures provided.Device history record review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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

It was reported via a clinical study that a patient underwent a bone fixation procedure.On an unknown time frame post-implantation, the patient presented with motion pain.Subsequently, the patient underwent revision surgery to remove the proximal locking screws.The tibial nail and distal screws remain implanted.Due diligence is complete as multiple attempts have been made; it was reported that no further information is available.

• Brand Name: UNKNOWN ZNN PROXIMAL LOCKING SCREW
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 15555523
• MDR Text Key: 301327650
• Report Number: 0001822565-2022-02904
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• 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: 10/10/2022
• 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
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male