MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, 9X160MM; AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL

Model Number	N/A
Medical Device Problem Codes	Mechanical Problem (1384); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical product: blunt tip screw, 4x44mm; catalog#: 47-2486-044-40; lot#: 3010653.Blunt tip screw, 4x46mm; catalog#: 47-2486-046-40; lot#: 3024714.Blunt tip screw, 4x60mm; catalog#: 47-2486-060-40; lot#: 3054546.Proximal humerus nail cap, 0mm; catalog#: 47-2488-010-00; lot#: 3033538.The manufacturer received x-rays and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.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).The following reports are associated with this event: 0009613350-2022-00127; 0009613350-2022-00128; 0009613350-2022-00129.
Event or Problem Description
It was reported that operation was performed with ann nail system.After 4 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.Patient involvement.No further outcome.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Investigation results are now available.D10 concomitant: cortical bone screw catalog# 47-2486-126-40; lot 3068970, cortical bone screw catalog# 47-2486-128-40; lot: 3068488, torque limiting handle catalog#27923;lot: n/a, proximal humerus nail cap, 0mm; catalog#: 47-2488-010-00; lot#: 3033538.Investigation and conclusion 1.Event description: it was reported that the patient underwent primary operation with an affixus natural nail on (b)(6), 2021.Four months later, it was discovered that the second most proximal screws migrated from the initial position despite the utilization of the corelock mechanism.The patient is being monitored and no revision surgery has been planned so far.Harm: s2 - instability, minor hazardous situation: implant deteriorates, breaks or loses function postoperatively.2.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.(b)(6).X-rays: two undated postoperative ap x-rays of the affected humerus have been received.One of the images shows the implant placement presumably directly post-implantation.The second image in comparison shows the second most proximal screw having migrated laterally.3.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.4.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: the quality records show that all specified characteristics have met the specifications valid at the time of production with no ncr with a potential correlation to the reported event was found.5.Conclusion: it was reported that the patient underwent primary operation with an affixus natural nail on (b)(6), 2021.Four months later, it was discovered that the second most proximal screws migrated from the initial position despite the utilization of the corelock mechanism.The patient is being monitored and no revision surgery has been planned so far.The quality records show that all specified characteristics have met the specifications valid at the time of production.The received x-rays confirm the reported event, namely that the second most proximal screw has migrated.No further medical documents such as surgical reports or office visit notes nor the complained product itself have been received.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, behaviour or implantation procedure.If and to what extent any of these aspects may have influenced the migration of the screw remains unknown.An additional deeper investigation was performed which identified the design limitation of the corelock mechanism as a potential contributing factor.However, as further biomechanical testing was carried out and the performance is in an acceptable range in comparison with legally marketed similar devices, no design changes were conducted.In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the migration of the screw.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00127 (device moved to concomitant will be voided) , 0009613350-2022-00128 (device moved to concomitant will be voided), 0009613350-2022-00129-1, 0009613350-2022-00216, 0009613350-2022-00217.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
Investigation results are now available.Attempts have been made and no further information has been provided.

• Brand Name: PROXIMAL HUMERUS, RIGHT, 9X160MM
• 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: 13666837
• Report Number: 0009613350-2022-00126
• Device Sequence Number: 14641637
• Product Code: HSB
• UDI-Device Identifier: 00889024505780
• UDI-Public: 00889024505780
• 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: 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): 04/01/2022

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47-2496-160-09
• Device Lot Number: 3033538
• 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: 02/11/2022
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2020
• 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; SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female