MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, LONG, 7X240MM; AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical product: proximal ann screw catalog#: unknown; lot#: unknown.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).

Event Description

It was reported that the proximal screws backed out after use of corelock technology.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6 correction: b4, g3, g6, h10.Event description: it was reported that the proximal screws in ann ph backed out after use of corelock technology.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: two undated x-ray pictures were received for investigation.The quality of the x-rays is sub-optimal.On one x-ray it can be seen that the third proximal screw and possibly the middle screw of the proximal screws have been backed out.Product evaluation: - no product was returned as they 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.- dhr review of the nail: review of the device history records identified no deviations or anomalies during manufacturing.- 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.Conclusion: it was reported that the proximal screws in ann ph backed out after use of corelock technology.The quality records show that all specified characteristics for the released parts have met the specifications valid at the time of production with no anomalies during manufacturing with a potential correlation to the reported event.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).The received x-rays confirm the reported event.It is unknown if the locking of the corelock during the primary implantation has not been performed as specified in the surgical technique using only the corelock driver with torque limiting handle.Based on the investigation it could be assumed that further possible contributing factors to the migration of the screws might be multifactorial related to either patient condition and behaviour, implantation procedure or design features.If and to what extent any of these aspects may have influenced the backing out of the screws remains unknown.In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the migration of the screws.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 Description

No change to previously reported event.

• Brand Name: PROXIMAL HUMERUS, RIGHT, LONG, 7X240MM
• Type of Device: 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: 12568535
• MDR Text Key: 278377665
• Report Number: 0009613350-2021-00510
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024505957
• UDI-Public: 00889024505957
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2496-240-07
• Device Lot Number: 3027920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.