MAUDE Adverse Event Report: ZIMMER GMBH NCB®, PT 3 HOLE TIBIAL PLATE, LATERAL, PROXIMAL, 13 HOLE, LEFT, 292 MM; PROSTHESIS, TRAUMA

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	05/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10.Ref (b)(4) lot unk cancellous screw 5.0 x1 ref (b)(4) lot unk cancellous screw 5.0 x3 ref (b)(4) lot unk cortical screw 4.0 x12 ref (b)(4) lot unk caps x6.G2.Report source: switzerland.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient had an open reduction internal fixation of the left tibia due to fractures sustained in a motorcycle accident.Nine weeks postoperatively, the patient was running backwards to catch an object and twisted his lower leg resulting in a torsional trauma.Subsequently, 10 days later the patient returned to surgery.The broken plate and all screws were removed, and an intramedullary tibial nail was placed without complications.Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
The reported ncb tibial plate as well as the associated screws and screw caps were returned to the post market surveillance team for investigation.A visual examination was performed, and the reported event of plate fracture can be confirmed.The plate has broken into two fragments.The fracture of the plate is located through a screw hole.There are scratches throughout the plate to be seen.The returned screws appear mainly inconspicuous.On one side of the fracture surface of the distal fragment, some beach marks are visible which point to a fatigue fracture.The fracture origins are located at the beginning of the chamfer on the non-bone-facing side.There appears to be a cauter mark present near the threaded area of the plate.The other side is covered in polished areas, likely due to contact between the parts after the fracture.The fracture surface of the proximal fragment does is also covered in polished surfaces.No clear beach lines can be seen.A review of all relevant device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint history found no additional related complaints for this item.Medical records/radiographs were provided and reviewed.The provided x-ray image dated confirms the breakage of the ncb tibial plate through a bore hole.Based on the investigation of the retrieval, a plate fracture can be confirmed and most likely attributed to fatigue.Nevertheless, since the cause may be multifactorial, consisting of patient- and/or procedure-related factors, a definitive root cause could not be identified.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 or Problem Description
Diligence is completed and no further information on the reported event has been provided.
Event or Problem Description
Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, d10, g3, g6, h2, h11.D10.Ncbâ®, cancellous screw, 㸠5.0 mm, 32 mm, 55 mm item# 0203152055 lot# unk.Ncbâ®, cancellous screw, 㸠5.0 mm, 32 mm, 80 mm item# 0203152080 lot# unk.Ncbâ®, locking cap item# 0203150300 lot# 4504711248.Ncbâ®, locking cap item# 0203150300 lot# 4504455748.Ncbâ®, locking cap item# 0203150300 lot# 4504455746.Ncbâ®, locking cap item# 0203150300 lot# 4504237649.Cortical screw 4.0 x12 item# unk lot# unk.Ncbâ®, screw, self-tapping, 㸠4.0 mm, 42 mm item# 0203155042 lot# 3077517.Ncbâ®, screw, self-tapping, 㸠4.0 mm, 28 mm item# 0203155028 lot# 3077654.Ncbâ®, screw, self-tapping, 㸠4.0 mm, 28 mm item# 0203155028 lot# 3132020.Ncbâ®, screw, self-tapping, 㸠4.0 mm, 28 mm item# 0203155028 lot# 3042170.Ncbâ®, screw, self-tapping, 㸠4.0 mm, 44 mm item# 0203155044 lot# 3042100.Ncbâ®, screw, self-tapping, 㸠4.0 mm, 36 mm item# 0203155036 lot# 3048890.Ncbâ®, screw, self-tapping, 㸠4.0 mm, 22 mm item# 0203155022 lot# 3042314.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 trend.

• Brand Name: NCB®, PT 3 HOLE TIBIAL PLATE, LATERAL, PROXIMAL, 13 HOLE, LEFT, 292 MM
• Common Device Name: PROSTHESIS, TRAUMA
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 19492754
• Report Number: 0009613350-2024-00221
• Device Sequence Number: 7106835
• Product Code: HRS
• UDI-Device Identifier: 00889024491953
• UDI-Public: (01)00889024491953(17)300131(10)3027606
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K192217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/20/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 0202261313
• Device Lot Number: 3027606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2024
• 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: 05/16/2024
• Supplement Date Received by Manufacturer: 10/25/2024; 12/16/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 10/31/2024; 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2020
• 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 H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 93 KG