MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X50MM; AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical product: blunt tip screw, 4x52mm; item# 47248605240; lot# 3002995.Blunt tip screw, 4x52mm; item# 47248605240; lot# 3010678.Proximal humerus, left, 11x160mm; item# 47249616111; lot# 2981136.Cortical bone screw, 4x32mm; item# 47248613240; lot# 3010610.Cortical bone screw, 4x34mm; item# 47248613440; lot# 2989741.Proximal humerus nail cap, 11x2.5mm; item# 47248801102; lot# 3008286.The manufacturer received x-rays and other source documents which will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.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 or Problem Description
Patient was implanted on an unknown side and underwent revision surgery due to backed out screw post 4 weeks of initial surgery.
Additional Manufacturer Narrative
Investigation results were made available.Review of event description: it was reported that initial operation was performed with ann nail system on (b)(6) 2020.After 4 weeks, surgeon noticed one of the implanted screw was backing out from the proper position.Therefore a revision surgery was performed.Moreover it was confirmed, that the corelock was locked after placing all the proximal screws and by using the torque screwdriver.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 images of proximal left humerus have been received and reviewed by hcp.Image 1: ap view, date unknown.Image 2: ap view with shoulder raised, date unknown.Image 3: ap view, date unknown.Assessment of imaging: image 2 performed prior to hardware placement in which there is the fracture through the humeral neck with displacement of the diaphysis slightly inferior from the humeral head.Assessment otherwise limited secondary to suboptimal positioning.Image 1 likely the initial postsurgical image demonstrating normal positioning of the hardware and normally positioned proximal and distal screws.Previously noted fracture of the humeral neck appears anatomically aligned.Image 3 is suspected to be the later postsurgical image as there is backing out of the 3rd most caudal screw located at the level of the humeral neck.The screw is backed out slightly laterally with a slight gap between th head of the screw and the lateral cortex of the humerus.Remainder of the hardware appears unchanged.No hardware fracture or detected periprosthetic lucency.Again noted anatomically aligned fracture of the humeral neck, possibly with some signs of healing.Impressions: humeral neck fracture affixed by intramedullary nail and proximal/distal interlocking screws.This suspected latest time point image demonstrates backing out of the 3rd most caudal screw.Overall fit and alignment of the implants appears normal.Bone quality appears normal.There are secondary signs of loosening in which the 3rd most caudal screw at the level of the humeral neck has backed out.However, no confirmed periprosthetic lucency.No contributing factors are detected.Product evaluation: visual examination: the screw of lot 3010669 has been returned for an investigation.There are slight deformations along the threads visible.Based on the returned product, is was determined that the screw has migrated.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.Conclusion: it was reported that initial operation was performed with ann nail system on (b)(6) 2020.After 4 weeks, surgeon noticed one of the implanted screw was backing out from the proper position.Therefore a revision surgery was performed.It was confirmed, that the corelock was locked after placing all the proximal screws and by using the torque screwdriver.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 evaluation of the received x-rays, the reported event can be confirmed.There was a backing out of the third most caudal humeral fixation screw.Based on the investigation it could be assumed that 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.Zimmer biomet's reference number of this file is (b)(4).
Event or Problem Description
No event update.Investigation results are now available.

• Brand Name: BLUNT TIP SCREW, 4X50MM
• Common Device Name: 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: 10633248
• Report Number: 0009613350-2020-00457
• Device Sequence Number: 3649526
• Product Code: HSB
• UDI-Device Identifier: 00889024505490
• UDI-Public: 00889024505490
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 47-2486-050-40
• Device Lot Number: 3010669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR