MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X60MM; AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number	N/A
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Migration (4003)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical product: cortical bone screw, 4x24mm; catalog#: 47-2486-124-40; lot#: 3068968.Cortical bone screw, 4x26mm; catalog#: 47-2486-126-40; lot#: 3054273.Cortical bone screw, 4x30mm; catalog#: 47-2486-130-40; lot#: 3064873.Proximal humerus nail cap, 0mm; catalog#: 47-2488-010-00; lot#: 3068908.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).
Event or Problem Description
It was reported that proximal screws were backed out from the proper position.
Additional Manufacturer Narrative
Investigation results were made available.Additional: h2, h6.Correction: b4, b5, d10, g3, g6, h10.D10: concomitant devices: cortical bone screw, 4x24mm; catalog#: 47-2486-124-40; lot#: 3068968, cortical bone screw, 4x26mm; catalog#: 47-2486-126-40; lot#: 3054273, cortical bone screw, 4x30mm; catalog#: 47-2486-130-40; lot#: 3064873, proximal humerus nail cap, 0mm; catalog#: 47-2488-010-00; lot#: 3068908, torque limiting handle, catalog#: 27923; lot#: unk.Review of event description: it was reported that 7 weeks after the initial surgery, the surgeon found the 1st, 3rd, and 5th screws of the proximal screws were backed out.No revision is planned.The corelock mechanism was engaged after placing all interlocking screws.Review of received data: no medical data 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; the products are still implanted, 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: review of the surgical technique (affixus natural nail proximal humeral system, 1927.3) identified that the interlocking screws should be locked using the corelock driver after the placement of all screws.It was noted that the surgeon followed the surgical technique.Conclusion: it was reported that 7 weeks after the initial surgery, the surgeon found the 1st, 3rd, and 5th screws of the proximal screws were backed out.No revision is planned.The corelock mechanism was engaged after placing all interlocking screws.Neither x-rays, operative notes, office visit notes, nor device(s) or photos of the device(s) were received; therefore the condition of the component(s) is unknown.Patient factors that may have affected the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.Based on the investigation the reported event cannot be confirmed.The investigation did not identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, we were not able to identify a specific root cause for the potential migration of the screws.However, further investigation has been initiated in order to determine the need of potential corrective and / or preventive actions.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 event update.Investigation results are now available.

• Brand Name: BLUNT TIP SCREW, 4X60MM
• 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
• 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: 12727599
• Report Number: 0009613350-2021-00553
• Device Sequence Number: 11841666
• Product Code: HSB
• UDI-Device Identifier: 00889024505544
• UDI-Public: 00889024505544
• 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): 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 47-2486-060-40
• Device Lot Number: 3048868
• 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: 10/08/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2020
• 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
• Patient Sex: Unknown