MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, 11X160MM; AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer received x-ray for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted with ann nail system on an unknown side, a week post initial surgery the surgeon noticed from the x-ray that one of the proximal screw had backed out, hence a revision surgery was performed during which the backed out screw was reinserted.
Additional Manufacturer Narrative
Investigation results were made available.Additional: h2, h6 correction: b4, b5, d10 g3, g6, h10 d10, concomitant medical products: cortical bone screw, 4x30mm, ref:47248613040, lot:3006025, cortical bone screw, 4x28mm, ref:47248612840, lot:3010599, proximal humerus nail cap, 0mm, ref:47248801000, lot:3008334.Review of event description: it was reported that initial operation was performed with ann nail system on (b)(6) 2020.After 1 week, surgeon noticed one of the implanted screw was backing out from the proper position.Therefore a revision surgery was performed on (b)(6) 2020 and the backed out screw was reinserted.No implants were explanted.Moreover, it was confirmed that the corelock was tightened after placing all the interlocking screws and by using the torque screwdriver.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: assessment of imaging: single ap film of the right humerus demonstrates an intramedullary rod with multiple proximal fixation screws.One of the screws does appear to have backed out.Fracture involving the greater tuberosity.No dislocation.Impressions: right humeral intramedullary rod with multiple fixation screws, one of which appears to have backed out.Overall fit of the implants is appropriate.The second superior most screw has backed out.Osteopenia is present.Evidence of an age indeterminate fracture of the greater tuberosity.Right humeral intramedullary rod with multiple fixation screws, one of which appears to have backed out.A fixation screw has backed out, the second superior most screw.Product evaluation: no product was returned for an investigation as they remain implanted.Review of product documentation: device purpose: all involved devices are intended for treatment.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that initial operation was performed with ann nail system on (b)(6) 2020.After 1 week, surgeon noticed one of the implanted screw was backing out from the proper position.Therefore a revision surgery was performed on (b)(6) 2020 and the backed out screw was reinserted.No implants were explanted.Moreover, it was confirmed that the corelock was tightened after placing all the interlocking screws and by using the torque screwdriver.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the evaluation of the received x-rays, the reported event can be confirmed.There was a backing out of the second most superior screw.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 (e.G.Oteopenia and inferior bone quality) and behavior, implantation procedure or design features.If and to what extent any of these aspects may have influenced the backing out 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.Further investigation has been initiated in order to determine the need of potential corrective and / or preventive actions.Zimmer biomet's reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2020-00459, 0009613350-2020-00467, 0009613350-2020-00461, 0009613350-2020-00463.
Event or Problem Description
No event update.Investigation results are now available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Additional: e1.Correction: b4, g3, g6, h10.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed again.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
No change to previously reported event.

• Brand Name: PROXIMAL HUMERUS, RIGHT, 11X160MM
• Common Device Name: AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10634688
• Report Number: 0009613350-2020-00469
• Device Sequence Number: 3650140
• Product Code: HSB
• UDI-Device Identifier: 00889024505797
• UDI-Public: 00889024505797
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2021

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: 47-2496-160-11
• Device Lot Number: 3007826
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 01/25/2021; 06/15/2021
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 02/18/2021; 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR