MAUDE Adverse Event Report: ZIMMER GMBH ZNN¿¢, CMN LAG SCREW, ø 10.5 MM, 90 MM, INCLUDING SET SCREW; ZNN TRAUMA IMPLANT

Model Number	N/A
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had an initial open reduction internal fixation on the left side.Subsequently, approximately 8 months post-implantation, revision was needed due to exit of the cervical screw from the joint and sinking into the acetabulum.During the revision it was noted that the acetabular roof was fractured.All components were exchanged with competitor product.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).D10: z nail 5.0x35 cort screw fa item # 47248403550 lot 65225702 anti-rotation pin 3.0mm - std item # 47249003004 lot 65206661.G2: foreign: france.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d9.G3; h2; h3; h6; h10 corrected: d4 the reported cmn nail and lag screw were returned to the post market surveillance team for examination.The nail appears mainly inconspicuous, with most of the signs of wear to be seen proximally near on or near the threaded interface.The lag screw exhibits signs of abrasion, noticeable as polished spirals near the threaded section.Attention is paid to the grooves of the lag screw.On one of the grooves, some polished surfaces perpendicular to the groove, but not within the groove, can be seen.The set screw was not returned to for examination.A review of the device manufacturing records confirmed no abnormalities or deviations.A review of the surgical technique "natural nail cephalomedullary standard surgtech" identified under subsection "lag screw placement" that "a set screw must be used to prevent the lag screw from rotating post-operatively." review of the complaint histories found no additional related complaints for these items and the reported part and lot combinations.An e-mail from the customer containing limited information on the primary procedure, excerpts of the revision report as well as radiographs were received.The information contained within was reviewed by a health care professional with the following findings: primary procedure: ¿ general anesthesia ¿ nail and screws placed without complication contributing factors of event: ¿ left pertrochanteric fracture revision surgery: ¿ diagnosis: scanning of a zimmer left hip nail with exit of the cervical screw from the joint and sinking into the acetabulum.¿ general anesthesia ¿ moore posterolateral approach ¿ nail excised easily ¿ excision of femoral head ¿ acetabulum roof found fractured ¿ competitor product placed without complications contributing factors of event: ¿ none noted the radiographs were reviewed by a radiologist with the following assessment: single view of the left hip demonstrates a left femoral intramedullary rod with one distal interlocking screw, a gamma nail in appropriate position within the central aspect of the femoral head and femoral neck as well as surgical skin staples consistent with recent placement.Of note, the set screw is poorly evaluated on this study given patient obliquity.Mild subcutaneous emphysema.Intertrochanteric hip fracture also with a vertically oriented fracture of the greater trochanter.Two views of the left hip a left femoral intramedullary rod with one distal interlocking screw and a gamma nail which now is asymmetric in position extending to the superior femoral acetabular joint space.The set screw does not appear to be fully placed and does not engage the lag screw.Vertically oriented fracture of the greater trochanter no longer seen suggesting healing.Healing of the intertrochanteric hip fracture also seen.Vascular calcifications.Based on the available information, the reported event can be confirmed.As per reviewed products and examination of the groove of the lag screw, some polished surfaces perpendiculares to the groove, but not within the groove, can be seen, potentially indicating incorrect placement and/or contact with the set screw.However, based on the given information and results of the investigation, a definitive root cause could not 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 or Problem Description
No additional event information at this time.

• Brand Name: ZNN¿¢, CMN LAG SCREW, ø 10.5 MM, 90 MM, INCLUDING SET SCREW
• Common Device Name: ZNN TRAUMA IMPLANT
• 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: 19383577
• Report Number: 0009613350-2024-00193
• Device Sequence Number: 4035672
• Product Code: HSB
• UDI-Device Identifier: 00889024298439
• UDI-Public: (01)00889024298439(17)241231(10)3015087
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K192312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

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 Expiration Date: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 47248509010
• Device Lot Number: 3015087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/13/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 62 KG