MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X60MM; AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer received 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.(b)(4).
Event or Problem Description
Patient was implanted on the right side and underwent revision surgery due to screws backed out.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Additional: d10, h2, h6 correction: b4, g4, g7, h10 event description: it was reported that initial operation was performed with ann nail system on (b)(6) 2020.After 2 weeks, surgeon noticed one of the proximal screws were backing out from the proper position.Therefore a revision surgery was performed.Moreover, it was confirmed that the corelock was tightened during initial surgery.During revision surgery, the proximal screws could be easily removed using forceps without loosening the corelock.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.- no medical data like x-rays have been received.Product evaluation: - visual examination: the explanted affixus nail, nail cap, 3 blunt tip screws and 3 cortical screws have been returned for an investigation.Nail: there are slight surface scratches.Moreover, the screw exit hole of the ascending screw exhibits wear.Nail cap: the nail cap shows slight deformation of the threads and screw head.36mm proximal screw: the 38mm proximal screw shows deformation and wear along the whole length of the threads.40mm proximal screw: the 40mm proximal screw shows deformation and wear along the whole length of the threads as well as one bone residual.60mm proximal screw: the 60mm proximal (ascending) screw shows extended deformation and wear along the distal 3/4 of the threads.Moreover, there are some bone residuals.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.Conclusion: it was reported that initial operation was performed with ann nail system on (b)(6) 2020.After 2 weeks, surgeon noticed one of the proximal screws were backing out from the proper position.Therefore a revision surgery was performed.Moreover, it was confirmed that the corelock was tightened during initial surgery.During revision surgery, the proximal screws could be easily removed using forceps without loosening the corelock.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).As no x-rays have been received, the migration of the screws cannot be recreated.The visual examination revealed deformation and wear on the screw¿s thread indicating movement between the screw and the nail.Therefore, based on the investigation the reported event can be confirmed.It cannot be determined, whether the polishing at the screw exit hole occurred during screw insertion, screw removal or due to movements between the nail and screw.Based on the investigation it could be assumed that possible contributing factors to the migration of the screw might be multifactorial related to patient condition and behavior, implantation procedure or design features.If and to what extent any of these aspects may have influenced the migration 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 and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
No change to previously reported event.

• Brand Name: BLUNT TIP SCREW, 4X60MM
• 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: 10884192
• Report Number: 0009613350-2020-00548
• Device Sequence Number: 11514533
• Product Code: HSB
• UDI-Device Identifier: 00889024505544
• UDI-Public: 00889024505544
• 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): 02/12/2021

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: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 47-2486-060-40
• Device Lot Number: 3024758
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 02/12/2021
• 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