MAUDE Adverse Event Report: ZIMMERSWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, LEFT, 9X160MM; AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number N/A

Device Problems Mechanical Problem (1384); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/30/2021

Event Type  Injury  

Manufacturer Narrative

Medical product: blunt tip screw, 4x44mm; item# 47248604440; lot# unknown.Blunt tip screw, 4x38mm; item# 47248603840; lot# unknown.Blunt tip screw, 4x40mm; item# 47248604040; lot# unknown.Blunt tip screw, 4x46mm; item# 47248604640; lot# unknown.Cortical bone screw, 4x32mm; item# 47248613240; lot# unknown.Therapy date: (b)(6) 2021.The manufacturer received x-rays and other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.Additional information has been requested and is currently not available.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

Patient was implanted on left side and was revised due to loosening of the proximal screws despite of corelock technology.

Event Description

Patient was implanted on left side and was revised due to loosening of the proximal screws despite of corelock technology.

Manufacturer Narrative

Additional information which was received on may 19, 2021.D10 - medical product : torque limiting handle; item# : 27923; lot# : 601270.Affixus pr hum corelock drvr; item# : 110035663; lot# : 4503366276.Therapy date: (b)(6) 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received x-rays and other source documents for review.Should any additional information become available or an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

Patient was implanted on the left side and underwent a revision surgery due to loosening of the proximal screws despite corelock technology.Pre and post diagnosis reveal bone necrosis in the upper arm.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additional information was received on jun 17, 2021.Additional: a2, b5.Correction: b4, g3, g6, h2, h10.The manufacturer received other source documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Manufacturer Narrative

Investigation results were made available.Review of event description: it was reported that the patient underwent primary implantation of a affixus natural proximal humeral nail on (b)(6) 2021 in the left humerus and underwent revision surgery on (b)(6) 2021 due to screw migration.The corelock mechanism has been reported as being engaged with the torque limiting handle after all the interlocking screws were placed.Review of received data: x-rays: two preoperative x-rays of the left humerus were received dated on (b)(6) 2021 showing calcar comminution.Four intra-operative fluoroscopy images were received dated on (b)(6) 2021, whereby three of these images show the intraoperative implant placement and one image shows the repositioning and reduction of the fractured off humeral head with the use of kirschner wires.On one of the fluoroscopy images showing the implant placement, the nail appears to have been inserted too deep.Additionally, no nail cap was utilized.Two post-implantation x-rays dated on (b)(6) 2021 were received.Four proximal screws as well as two distal screws without any notable conspicuousness can be seen.No ascending screw, but instead a descending screw was implanted.Bone formation can be seen in the area around the distal screws.Two additional x-rays, dated on (b)(6) 2021, have been received.Compared to the previous x-rays, the first and second most proximal screws are confirmed to have migrated.Surgical report: the implantation record dated on (b)(6) 2021 has been received.Indication for surgery is a proximal humerus fracture with "other" and multiple localization.The surgery conducted was an open reduction of a multi-fragment fracture in the joint region of a long tubular bone with osteosynthesis of the proximal humerus by intramedullary nail.The implanted products by item number have been provided.The revision record dated on (b)(6) 2021 has been received.Indication for surgery is secondary bone necrosis of the upper arm.All devices were explanted and an inverse total shoulder endoprosthesis was implanted.Patient data: (b)(6)., female, dob on (b)(6) 1919.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: document review could not be performed due to unknown product identification.Device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Conclusion: it was reported that the patient underwent primary implantation of a affixus natural proximal humeral nail on (b)(6) 2021 in the left humerus and underwent revision surgery on (b)(6) 2021 due to screw migration.The corelock mechanism has been reported as being engaged with the torque limiting handle after all the interlocking screws were placed.The quality records of the involved products could not be reviewed as the lot number of the devices have not been provided.Therefore, no nonconformance or a complaint out of box (coob) could be identified.The received x-rays confirm the reported event, namely that proximal screws have migrated.On one of the received fluoroscopy images showing the implant placement, 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.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 and behavior, implantation procedure or design features.If and to what extent any of these aspects may have influenced the backing out of the screw remains unknown.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 for the time being and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).

Event Description

No event update.Investigation results are now available.

• Brand Name: PROXIMAL HUMERUS, LEFT, 9X160MM
• Type of Device: AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL
• Manufacturer (Section D): ZIMMERSWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11840470
• MDR Text Key: 251121394
• Report Number: 0009613350-2021-00218
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024505810
• UDI-Public: 00889024505810
• Combination Product (y/n): N
• PMA/PMN Number: K200814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• 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: 47-2496-161-09
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: REFER H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 101 YR