MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANN, BLUNT TIP SCREW, 4X48MM; ROD, FIXATION, INTRAMEDULLARY

Model Number	N/A
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Codes	Failure of Implant (1924); Necrosis (1971)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 6 weeks after implantation, patient experienced humeral head necrosis.Proximal screw next to the screw hole had migrated.Revision surgery has been performed on an unknown date.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: ann ph nail rt9x160mm; item# 47249616009; lot# 3067307, ann blunt tip screw 4x48mm; item# 47248604840; lot# 3068481, ann blunt tip screw 4x40mm; item# 47248604040; lot# 3076831, ann blunt tip screw 4x42mm; item# 47248604240; lot# 3076739, ann cort bone screw 4x24mm; item# 47248612440; lot# 3081954, ann cort bone screw 4x26mm; item# 47248612640; lot# unknown.Foreign source: germany.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00272, 0009613350-2022-00273, 0009613350-2022-00439, 0009613350-2022-00440.The products were returned for examination.Signs of wear on the threads of the blunt tip screws are minimal to non-existant, which is uncommon for migration cases.Additionally, the received nail has minimal scratches up until the proximal bore holes, where the 3rd most proximal hole has several scratches at the chamfer, likely originating from vibration or migration of the screw.The corelock mechanism is still contained within the nail.The cortical screws are inconspicuous.Review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.Medical records in the form of x-rays were provided.The post-operative x-rays are ap views, with the humerus in one of the images being internally rotated.A serious fracture of the humerus is clearly visible.The lateral pre-operative image is not of much merit to the investigation, however shows an anterior dislocation of the humeral head.The second pre-operative image shows clear signs of humeral head necrosis.A possible screw migration can not be assessed due to the rotation of the humerus in comparison with the post-operative x-ray.Based on the investigation it could be assumed that further possible contributing factors to the migration of the screw might be multifactorial related to either patient condition, behavior or implantation procedure.Of note is the evident humeral head necrosis as seen on the x-rays, which likely caused or contributed to the reported event of screw migration.The cause of humerhal head necrosis however is unknown, but might be related to the severity of the humeral head fracture sustained prior to implantation of the devices.If and to what extent any of these aspects may have influenced the migration of the screw remains unknown.The design limitation of the corelock mechanism was also investigated as a potential contributing factor.However, biomechanical testing determined that the product performance is in an acceptable range in comparison with legally marketed similar devices.In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the migration of the screw.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.

• Brand Name: ANN, BLUNT TIP SCREW, 4X48MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 15354788
• Report Number: 0009613350-2022-00441
• Device Sequence Number: 1635786
• Product Code: HSB
• UDI-Device Identifier: 00889024505483
• UDI-Public: (01)00889024505483(17)260331(10)3073797
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/29/2022

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 Expiration Date: 03/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 47-2486-048-40
• Device Lot Number: 3073797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2022
• 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: 08/15/2022
• Initial Report FDA Received Date: 09/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2021
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Sex: Female