MAUDE Adverse Event Report: ZIMMER MANUFACTURING SWITZERLAND GMBH PROXIMAL HUMERUS, LEFT, 9X160MM; ROD, FIXATION, INTRAMEDULLARY

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Failure of Implant (1924); Discomfort (2330)
Date of Event	10/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 3-month post-implantation, the patient underwent revision surgery due to migrated screws.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products; blunt tip screw, 4x46mm , item# 47248604640 lot# 3078231.Blunt tip screw, 4x48mm , item# 47248604840 lot# 3076807.Blunt tip screw, 4x50mm , item# 47248605040 lot# 3068482.Torque limiting handle , item# 27923 lot# n/a.Report source: foreign: japan.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 -2022 -00578, 0009613350 -2022 -00579, 0009613350 -2022 -00580.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.All three explanted proximal blunt tip screws were returned for investigation.All three screws exhibit the same phenomena of several flattened and polished threads.This most likely occurred due to direct contact between the screw and the affixus natural nail, which likely is a result of screw migration.The longest of the three screws (4x50mm) additionally has a small speck of bone ongrowth between one of the thread flanks, located approximately halfway of the length of the screw threads and in the area where signs of screw migration are visible.Review of the device history records identified no deviations or anomalies during manufacturing with a potential correlation to the reported event.Devices are used for treatment.Radiographic images: x-rays were reviewed by external hcp (mmi radiologist) with the following assessment: postoperative images demonstrate comminuted fracture of the humeral neck affixed by intramedullary nail with proximal locking screws.Alignment is normal and hardware is intact.Skin staples noted surrounding the shoulder.The received x-rays confirm the reported event, namely that the proximal screw have migrated.This phenomenon is supported by the visual examination of the received proximal screws, which show flattened and polished threads, likely occurring due to direct contact between the screw and the nail.Of note however, is that the quality of the radiographic images is not optimal, as the images where photographed and limited postoperative views of the affected humerus were provided.No further medical documents such as surgical reports or office visit notes have been received.Based on the investigation it could be assumed that possible contributing factors to the migration of the screw might be multifactorial related to either patient condition, behaviour or implantation procedure.If and to what extent any of these aspects may have influenced the migration of the screw remains unknown.In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the migration of the screw.The investigation also considered whether the design limitation of the corelock mechanism could be a potential contributing factor.However, further biomechanical testing identified that the product performance is in an acceptable range in comparison with legally marketed similar devices.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 further event information available at the time of this report.

• Brand Name: PROXIMAL HUMERUS, LEFT, 9X160MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): ZIMMER MANUFACTURING SWITZERLAND GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER MANUFACTURING SWITZERLAND 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: 15758010
• Report Number: 0009613350-2022-00581
• Device Sequence Number: 8245808
• Product Code: HSB
• UDI-Device Identifier: 00889024505810
• UDI-Public: (01)00889024505810(17)310726(10)3083154
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181827
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2496-161-09
• Device Lot Number: 3083154
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Race: Asian