MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, 11X160MM; AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 01/06/2022

Event Type  Injury  

Event Description

It was reported that operation was performed with ann nail system.After 2 weeks from the initial, surgeon found the proximal screw was backed out from the proper position.Therefore, revision surgery was performed.Pain at the fracture site.Pain due to screw protrusion.

Manufacturer Narrative

Concomitant medical products: therapy date: (b)(6) 2022.Blunt tip screw, 4x44mm; catalog#: 47-2486-044-40; lot#: 3068471.Blunt tip screw, 4x44mm; catalog#: 47-2486-044-40; lot#: 3068472.Torque limiting handle; catalog#: 27923; 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).The following reports are associated with this event: 0009613350-2022-00131.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Investigation and conclusion: it was reported that the patient was implanted with an ann nail on (b)(6) 2021.After 2 weeks, the surgeon found the proximal screw backed out from the proper position.The patient experienced pain due to the screw protrusion.During the revision surgery on (b)(6) 2022, the blunt screw was removed and the corelock was re-tightened.Harm: s3 - instability, moderate.Hazardous situation: loss of fixation or non-integration of an implant.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-ray analysis: two undated radiographs of the right shoulder were received.On one of the two x-rays, the proximal blunt screw seems backed out.Product evaluation: no product was returned; therefore, visual 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: review of the device history records of the nail and the proximal blunt screw identified no deviations or anomalies during manufacturing.Surgical technique: review of the surgical technique 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.Complaint history was run and additional complaints were found for the same article/lot number.Capa ca-06074 is ongoing to address this matter.Conclusion: it was reported that the patient was implanted with an ann nail on (b)(6) 2021.After 2 weeks, the surgeon found the proximal screw backed out from the proper position.The patient experienced pain due to the screw protrusion.During the revision surgery on (b)(6) 2022, the blunt screw was removed and the corelock was re-tightened.The investigation did identify a nonconformance or a complaint out of box (coob).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, behavior or implantation procedure.If and to what extent any of these aspects may have influenced the migration of the screw remains unknown.A deeper investigation was performed (refer to ca-06074) which identified the design limitation of the corelock mechanism as a potential contributing factor as well.However, further biomechanical testing was carried out and as the product performance is in an acceptable range in comparison with legally marketed similar devices, no design changes were conducted (refer to ca-06074).In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the migration of the screw.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, 11X160MM
• 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: 13692814
• MDR Text Key: 286756187
• Report Number: 0009613350-2022-00130
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024505797
• UDI-Public: 00889024505797
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2496-160-11
• Device Lot Number: 3026581
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2020
• 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