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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, LONG, 8.5X260MM AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL

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ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, LONG, 8.5X260MM AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL Back to Search Results
Model Number 47-2496-260-08
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Failure of Implant (1924)
Event Date 01/06/2022
Event Type  Injury  
Manufacturer Narrative
This combined report is being submitted to relay corrected information. As part of the investigation it was determined that the nail here reported, may also be a contributing factor for the reported event. Therefore it has been moved from concomitant device. Reported in 0009613350-2022-00099 to a main device. Zimmer biomet reference: (b)(4). Investigation results are now available. Investigation and conclusion: 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. 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) 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. 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. 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. 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
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. Attempts have been made and no further information has been provided. Investigation results are now available. As part of the investigation it was determined that the nail here reported, may also be a contributing factor for the reported event. Therefore it has been moved from concomitant to main device and this initial and final combined report is being filed.
 
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Brand NamePROXIMAL HUMERUS, RIGHT, LONG, 8.5X260MM
Type of DeviceAFFIXUS 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 Key13976367
MDR Text Key289179046
Report Number0009613350-2022-00218
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K181827
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number47-2496-260-08
Device Catalogue Number47-2496-260-08
Device Lot Number3038171
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/01/2022 Patient Sequence Number: 1
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