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

Model Number N/A

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: cortical bone screw, ã¿ 4x28mm; catalog no#: 47-2486-128-40; lot#: 3010598.Cortical bone screw, ã¿ 4x30mm; catalog no#: 47-2486-130-40; lot#: 2999921.Proximal humerus nail cap, 0mm; catalog no#: 47-2488-010-00; lot#: 3008334.Therapy date: (b)(6) 2020.The manufacturer did receive x-rays and implant pictures for review.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

Patient was implanted on the unknown side and underwent revision surgery due to screws were backed out.

Manufacturer Narrative

Event description: it was reported that initial surgery was performed with ann nail system on (b)(6) 2020.After 1 week, surgeon noticed that three of the implanted proximal screws were backing out from the proper position.Therefore, a revision surgery was performed on (b)(6) 2020.During implantation surgeon locked the corelock using the non-torque screwdriver.During revision surgery, surgeon was able to explant the three proximal screws by hand without loosening the corelock.The launch screw however was locked tightly.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: three x-rays of the right humerus were received and reviewed by an radiologist.Summary of imaging: three views of the right humerus.Assessment of imaging: three views of the right humerus demonstrate a right humeral intramedullary rod with associated comminuted fracture of the proximal right humeral diaphysis.On image one, three, and four, there are three proximal screws.On image two, there is suggestion of an additional screw obliquely oriented within the proximal humeral diaphysis extending into the humeral head.Differences in technique between the films limits evaluation of screw position.Impressions: 1.Comminuted fracture of the proximal humeral diaphysis with placement of an additional obliquely order screw extending from the proximal humeral diaphysis extending into the humeral head.Comparison of screw position is limited given differences in technique.Overall fit and alignment of the implant is appropriate.An additional screw is seen on image two.Comparison of screw position is limited secondary to differences in technique between the imaging studies.No signs of loosening, radiolucency.No event can be confirmed.There is a comminuted fracture of the proximal humeral diaphysis on all three images.Note: comparing the returned products to the x-rays, most likely all 4 screws were implanted during the whole time in-vivo.However, due to the angle of the x-ray, not all screws are visisble.Product evaluation: visual examination: the explanted affixus nail, nail cap, 4 blunt tip screws and 2 cortical screws have been returned for an investigation.Nail: there are slight scratches at the distal and proximal end.Moreover, there is an dent at the screw exit hole of the ascending screw.Nail cap: the nail cap shows slight deformation of the threads and screw head.38mm proximal screw: the 38mm proximal screw shows slight deformation of the threads.40mm proximal screw lot 3006462 (4503144607): the 40mm proximal screw lot 3006462 shows slight deformation of the threads.40mm proximal screw lot 3024681 (4503144682): the 40mm proximal screw lot 3024681 shows slight deformation of the threads.60mm proximal screw: the 60mm proximal (ascending) screw shows slight deformation of the screw head and heavy deformation of the threads.Cortical screws :the cortical screws show some deformation of the threads and screw heads.Review of product documentation: device purpose: all involved devices are intended for treatment.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Surgical technique: the surgical technique 197-glbl-en 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 3-4 clicks are felt from the torque limiting handle.Conclusion: it was reported that initial surgery was performed with ann nail system on 08 sep 2020.After 1 week, surgeon noticed that three of the implanted proximal screws were backing out from the proper position.Therefore a revision surgery was performed on (b)(6) 2020.During implantation surgeon locked the corelock using the non torque screwdriver.During revision surgery, surgeon was able to explant the three proximal screws by hand without loosening the corelock.The launch screw however was locked tightly.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the received x-rays the screw migration cannot be recreated.The visual examination revealed slight to heavy deformation on the screw¿s thread indicating movement between the screw and the nail.Therefore, based on the investigation the reported event can be confirmed.The locking of the corelock has not been performed as specified in the surgical technique using the corelock driver with torque limiting handle.Instead, a non-torque screwdriver was used.It cannot be determined whether sufficient torque has been applied while locking the corelock.Therefore, it remains unknown, whether this deviation from the surgical technique might have contributed to an insufficient locking of the corelock resulting in screw migration.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 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 screw.The need for corrective measures is not indicated and zimmer 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(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10598838
• MDR Text Key: 209027631
• Report Number: 0009613350-2020-00433
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024505797
• UDI-Public: 00889024505797
• 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
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 2988086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 86 YR