MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X46MM; AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number N/A

Device Problems Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

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

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

Medical products: blunt tip screw, 4x42mm; catalog#: 47-2486-042-40; lot#: 3048176; blunt tip screw, 4x44mm; catalog#: 47-2486-044-40; lot#: 3024702; blunt tip screw, 4x44mm; catalog#: 47-2486-044-40; lot#: 3054470; torque limiting handle; catalog#: 27923; lot#: 601270; proximal humerus corelock driver, hex, 4mm; catalog#: 110035663; lot#: 4503366276; proximal humerus, left, 9x160mm; catalog#: 47-2496-161-09; lot#: 3049742; cortical bone screw, 4x30mm; catalog#: 47-2486-130-40; lot#: 3024383.Therapy date: (b)(6) 2021.The manufacturer received x-rays for review.Other documents were received 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).

Event Description

Patient was implanted on the left side and underwent a revision surgery due to loosening and migration of proximal screws despite corelock technology.

Event Description

No change to previously reported event.

Manufacturer Narrative

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, which was discovered during postoperative radiograhic examination.Additionally, the corelock mechanism has been reported as being engaged with the torque limiting handle.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: two undated pre-operative ap x-ray images showing calcar comminution were received.Two undated fluoroscopy images of the affected humerus were received, whereby one of the images shows the proximal intramedullary nail and screw placement and the second image shows the distal intramedullary nail and screw placement.Two post-operative axillary x-ray views of the left humerus have been received, which show a displaced humeral head as well as the migration of proximal screws.Furthermore, four fluoroscopy images of the devices implanted (total shoulder arthroscopy, inverse configuration) during the revision surgery have been received.Additionally, these images have been reviewed by the mmi group (external hcp, radiology), whereby the following assessment has been made: initial radiographs demonstrate a moderately displaced proximal humerus fracture.Fluoroscopic images demonstrate intramedullary nail and screw placement.Post-operative imaging demonstrates surgical skin staples.While the projections are not the same, two of the proximal screws appear to have retracted.- surgical report: the implantation record dated (b)(6) 2021 has been received.Indication for surgery was a fracture of the proximal end of the humerus: collum chirurgicum - left.The procedure carried out was a closed reduction of a fracture or epiphyseal loosening with osteosynthesis: by intramedullary nail with joint components: humerus proximal - left.Additionally, the implanted components have been listed as well as the corresponding item number, lot number and quantity.- patient data: (b)(6) 1931, female.Product evaluation: - no explanted devices were returned for investigation; therefore, visual and dimensional evaluation for these devices could not be performed.However, the involved corelock hex driver as well as the torque limiting handle were returned for investigation.- visual examination: the visual examination of the returned instruments show no obvious signs of any conspicuousness, apart from normal signs of use.- functional test: a functional test was performed with a torque sensor and three measurements were obtained: 1.87nm, 1.88nm and 1.80nm.These three measurements are according to specification (17 in-lb of torque +/- 2.0 in-lb (in metric units 1.92nm +/- 0.226nm)).In reference to the mentioned specification and the provided specification on the product drawing.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.- dhr review: review of the device history records identified no deviations or anomalies during manufacturing with a potential correlation to the reported event.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, which was discovered during postoperative radiographic examination.Additionally, the corelock mechanism has been reported as being engaged with the torque limiting handle.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).The received x-ray and fluoroscopy images confirm the reported event, namely that proximal screws have migrated.In addition to this, a displaced humeral head can be identified in the post-operative x-rays.However, based on the received information and the investigation it is not possible to identify which phenomena occurred at what point in time (e.G.If the displacement of the humeral head occurred before or after the screw migration) and why.It remains unknown if one of the mentioned phenomena could possibly have triggered the other or contributed to it, or are a concomitant of it.No explanted devices were returned for investigation; therefore, visual and dimensional evaluation for these devices could not be performed.However, the involved corelock hex driver as well as the torque limiting handle were returned for investigation.A functional measurements with a torque sensor showed that the instrument works according to specification.Additionally, 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.Further investigation has been initiated in order to determine the need of potential corrective and / or preventive actions.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).

• Brand Name: BLUNT TIP SCREW, 4X46MM
• 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: 11907455
• MDR Text Key: 253466626
• Report Number: 0009613350-2021-00248
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024505476
• UDI-Public: 00889024505476
• 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: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2021
• 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: 47-2486-046-40
• Device Lot Number: 3024721
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 90 YR