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

Catalog Number	47248404750
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369); Ambulation or Postural Difficulties (2544)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Year of birth: 1989.Medical product: tibial nail - yellow 9.3 mm diameter 34 cm length: catalog#47249534009, lot#ni; tibial nail cap 10 mm height: catalog#47248700510, lot#ni; unknown zimmer natural nail dynamization proximal screw: catalog#ni, lot#ni.Foreign: germany.Multiple mdr reports have been filed for this event, please see associated reports: 0001822565-2023-01927; 0001822565-2023-01928; 0001822565-2023-01929.The product will not be returned to zimmer biomet for evaluation as the product remains implanted.The investigation is in progress.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.See h10 narrative.
Event or Problem Description
It was reported via a clinical study that a patient underwent an initial tibial bone fixation procedure.Subsequently, ten (10) months post-implantation, it was revealed that the fracture showed delayed union.The patient underwent spongiosa plastic surgery with plate fixation and removal of the secondary proximal screw.The outcome is pending as the patient may still need a full revision of the tibial nail due to the non-union.Due diligence is in progress for this event; to date no further information has been reported.
Additional Manufacturer Narrative
This follow up report is being submitted to relay additional information.The following sections have been updated/corrected: b4; b5; d1; d4; g3; h2; h4; h6; h10.Upon reassessment of the reported event, the previously reported cortical screw has been determined to be not reportable.The implanted tibial nail is the device that acts as the uniting mechanism intended to restore the natural anatomy of the tibia when treating tibial shaft fractures.Therefore, the associated screw has not contributed to the reported complication of bone nonunion.The patient's pain and ambulation difficulties can likewise be attributed to the bone nonunion.
Event or Problem Description
It was reported that a patient underwent an initial right tibial bone fixation procedure following involvement in a motor vehicle accident.Subsequently, five (5) months post-implantation, it was revealed that the fracture showed delayed union.The patient underwent additional procedures to assist with fracture fixation and address the delayed healing.The surgeon has since stated that there is no chance of recovery or union due to the extent of the injuries, and no revision is currently planned until further review of the patient¿s healing progress at the one year follow up.Upon reassessment of the reported event, the previously reported cortical screw has been determined to be not reportable.The implanted tibial nail is the device that acts as the uniting mechanism intended to restore the natural anatomy of the tibia when treating tibial shaft fractures.Therefore, the associated screw has not contributed to the reported complication of bone nonunion.The patient's pain and ambulation difficulties can likewise be attributed to the bone nonunion.
Event or Problem Description
It was reported that a patient underwent an initial right tibial bone fixation procedure.Subsequently, five (5) months post-implantation, it was revealed that the fracture showed delayed union.The patient underwent spongiosa plastic surgery with plate fixation of the cancellous bone and removal of the secondary proximal screw.The current outcome of the patient is pending.Due diligence is in progress for this event; to date no further information has been reported.
Additional Manufacturer Narrative
This follow up report is being submitted to relay additional information.D10: medical product: tibial nail - yellow 9.3 mm diameter 34 cm length: catalog#47249534009, lot#ni; tibial nail cap 10 mm height: catalog#47248700510, lot#ni; unknown zimmer natural nail dynamization proximal screw: catalog#ni, lot#ni; unknown mesh: catalog#ni, lot#ni; unknown tibial screw: catalog#ni, lot#ni; unknown femoral nail: catalog#ni, lot#ni.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.

• Brand Name: 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD
• Common Device Name: ROD, FIXATION
• 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: 17338516
• Report Number: 0001822565-2023-01930
• Device Sequence Number: 6477815
• Product Code: HSB
• UDI-Device Identifier: 00889024094147
• UDI-Public: (01)00889024094147(17)310221(10)65028053
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 47248404750
• Device Lot Number: 65028053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 07/18/2023; 08/04/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/08/2023; 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 96 KG