MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, LEFT, LONG, 8.5X220MM; AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL

Model Number	N/A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that operation was performed with ann nail system.After 2 months from the initial, surgeon found a screw of the proximal screws was backed out from the proper position.The surgeon keep an eye on the patient condition as well as no revision will be planned so far.
Additional Manufacturer Narrative
Concomitant medical products: ann cort bone screw 4 x 26mm; catalog#: 47-2486-126-40; lot#: 3054512.Ann cort bone screw 4 x 28mm; catalog#: 47-2486-128-40; lot#: 3054458.Affixus ph nl cap 0mm; catalog#: 47-2488-010-00; lot#: 3076770.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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).The following reports are associated with this event: 0009613350-2022-00104; 0009613350-2022-00105; 0009613350-2022-00106; 0009613350-2022-00107.
Additional Manufacturer Narrative
Concomitant medical products: ann cort bone screw 4 x 26mm; catalog#: 47-2486-126-40; lot#: 3054512.Ann cort bone screw 4 x 28mm; catalog#: 47-2486-128-40; lot#: 3054458.Affixus ph nl cap 0mm; catalog#: 47-2488-010-00; lot#: 3076770.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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).The following reports are associated with this event: 0009613350-2022-00104; 0009613350-2022-00105; 0009613350-2022-00106; 0009613350-2022-00107.
Event or Problem Description
It was reported that operation was performed with ann nail system.After 2 months from the initial, surgeon found a screw of the proximal screws was backed out from the proper position.The surgeon keep an eye on the patient condition as well as no revision will be planned so far.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Event description: it was reported that operation was performed with ann nail on (b)(6) 2021.After 2 months from the initial, surgeon found #2 screw of the proximal screws was backed out from the proper position.The surgeon keep an eye on the patient condition as well as no revision will be planned so far.No further outcome.Review of received data: no medical data (like x-rays or medical records) relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Surgical technique sap: the surgical technique explains that the locking of the corelock is done using the corelock driver with torque limiting handle.Turn slowly clockwise to tighten and engage the corelock mechanism until a click is felt from the torque limiting handle.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Complaint history review: review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination related to the event.Conclusion: it was reported that operation was performed with ann nail on (b)(6), 2021.After 2 months from the initial, surgeon found #2 screw of the proximal screws was backed out from the proper position.The surgeon keep an eye on the patient condition as well as no revision will be planned so far.No further outcome.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 investigation it can be assumed that the factors that led and/or contributed to the migration of the screw might be multifactorial related to either patient condition, behaviour, 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.Capa ca-06074 is ongoing for this issue of screw backing out.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.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, LEFT, LONG, 8.5X220MM
• Common Device Name: AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL
• 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: 13583791
• Report Number: 0009613350-2022-00108
• Device Sequence Number: 17235349
• Product Code: HSB
• UDI-Device Identifier: 00889024505933
• UDI-Public: 00889024505933
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2022

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: 47-2496-221-08
• Device Lot Number: 3026730
• 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: 01/26/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2020
• 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
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown