MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 47249536010 tibial nail, yellow 10 mm diameter 36 cm length use red proximal and red distal screws.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient was revised due to material dislocation of the distal locking screw with no evidence of dislocation of the fracture.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported the patient was revised approximately 4 days post implantation due to material dislocation of the distal locking screw with no evidence of dislocation of the fracture.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: a2; b3; b5; d6;.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d1; d2; d4; d10: g4; h4.D4: the part number, lot number, expiration date, and udi number is one of the following: 47248403550, 63791221, sep 30, 2027, (b)(4).47248402750, 63791223, sep 30, 2027, (b)(4).47248402750, 63766373, aug 31, 2027, (b)(4).47248403250, 63799279, oct 31, 2027, (b)(4).47248403050, 63779928, aug 31, 2027, (b)(4).D10: 47249536010 63619735 tibial nail - yellow 10 mm diameter 36 cm length use red proximal and red distal screws.H4: the manufacturing number is one of the following: 47248403550, 63791221, sep 18, 2017.47248402750, 63791223, sep 18, 2017.47248402750, 63766373, aug 21, 2017.47248403250, 63799279, oct 9, 2017.47248403050, 63779928, sep 5, 2017.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Medical records were provided and reviewed by a health care professional.Review of the available records identified initial operation.No nail available in the 380mm length, a 360mm nail is chosen, when drilling for locking screw fibula is accidentally drilled through without risk of fracture, therefore plating is omitted.No revision op notes provided.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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

No further event information available at the time of this report.

• Brand Name: 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12443818
• MDR Text Key: 270485959
• Report Number: 0001822565-2021-02526
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/16/2022

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/26/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 10/05/2021; 11/11/2021; 11/11/2021; 01/14/2022
• Supplement Dates FDA Received: 11/02/2021; 11/23/2021; 11/24/2021; 01/18/2022
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 75 KG