MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X44MM; AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL

Model Number N/A

Device Problems Patient Device Interaction Problem (4001); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 01/06/2022

Event Type  Injury  

Manufacturer Narrative

Medical product: ann ph nail rt 8.5x260mm; catalog#: 47-2496-260-08; lot#: 3038171.Therapy date: (b)(6) 2022.The manufacturer received x-rays and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.Lot number were received for the device, 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 there was a revision surgery due to migration.Screw toggled out of the nail, even with the core lock that was locked during surgery.

Event Description

It was reported that there was a revision surgery due to migration.Screw toggled out of the nail, even with the core lock that was locked during surgery.

Manufacturer Narrative

Medical product: ann ph nail rt 8.5x260mm; catalog#: 47-2496-260-08; lot#: 3038171.Therapy date: (b)(6) 2022.The manufacturer received x-rays and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.Lot number were received for the device, 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).

Manufacturer Narrative

This follow-up report is being submitted to relay corrected information.Product has been received by zimmer biomet investigation results are now available.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 one of the proximal screws migrated from the initial position despite the utilization of the corelock mechanism.A revision surgery was performed on (b)(6), 2022, whereby the migrated screw was explanted.Harm: s3 - instability, moderate 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.Further correspondence from trauma development regarding nail positioning has been received and analyzed.X-rays: three postoperative ap x-rays of the right humerus dated (b)(6), 2021, (b)(6), 2021 and (b)(6), 2022 have been received.The quality of these x-rays are poor quality as they have been photographed.The image dated (b)(6), 2021 is taken the day after implantation and shows implant placement.The nail appears to have been inserted too deep and without a nail cap.The implant positioning seems unchanged on the follow-up imaging taken on (b)(6), 2021, despite the shoulder being in an externally rotated position.The image dated (b)(6), 2022 shows the most proximal screw having migrated laterally when compared with the other two images taken on prior dates.3.Product evaluation: visual examination: the explanted blunt tip screw 4 x 44mm was returned for investigation.The visual examination of the returned screw shows flattened and polished thread flanks.This most likely occurred due to direct contact between the screw and the affixus natural nail, which likely is a result of screw migration.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.Correspondence with trauma development is captured in the complaint file 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 one of the proximal screws migrated from the initial position despite the utilization of the corelock mechanism.A revision surgery was performed on (b)(6), 2022, whereby the migrated screw was explanted.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 a proximal screw has migrated.This phenomenon is supported by the visual examination of the received screw, which shows flattened and polished thread flanks, likely occurring due to direct contact between the screw and the nail.Additionally, on the x-ray taken the day after implantation and showing the implant positioning, the nail appears to have been inserted too deep and without a nail cap.However, to what extent the position of the nail may have affected the course of the event remains unknown.Of additional note is that the quality of the images is not optimal.No further medical documents such as surgical reports or office visit notes have been received.Based on the investigation it could be assumed that further possible contributing factors to the migration of the screw might be multi-factorial related to either patient condition, behavior 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 multi-factorial an exact root cause could not be identified for the migration of the screw.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 Description

Investigation results are now available.Attempts have been made and no further information has been provided.

• Brand Name: BLUNT TIP SCREW, 4X44MM
• Type of Device: 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: 13583766
• MDR Text Key: 285988398
• Report Number: 0009613350-2022-00099
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024505469
• UDI-Public: 00889024505469
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K181827
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47-2486-044-40
• Device Lot Number: 3024702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2020
• 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
• Patient Outcome(s): Required Intervention; Hospitalization