MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X38MM; AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Pain (1994); Unspecified Tissue Injury (4559)

Event Date 05/27/2021

Event Type  malfunction  

Manufacturer Narrative

Medical products: proximal humerus, left, 9x160mm; catalog#: 47-2496-161-09; lot#: 3033566, blunt tip screw, 4x38mm; catalog#: 47-2486-038-40; lot#: 3054317, blunt tip screw, 4x40mm; catalog#: 47-2486-040-40; lot#: 3064863, blunt tip screw, 4x42mm; catalog#: 47-2486-042-40; lot#: 3054544, cortical bone screw, 4x24mm; catalog#: 47-2486-124-40; lot#: 3054496, proximal humerus nail cap, 10.5x2.5mm; catalog#: 47-2488-010-02; lot#: 3054395, cortical bone screw, 4x24mm; catalog#: 47-2486-124-40; lot#: 30224294.Therapy date: unknown.The manufacturer received x-rays and other source documents 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 an unknown side and 3 weeks post implantation, it was noticed that the proximal screw loosened and started damaging the arm soft tissue.Revision surgery has not been performed yet.

Manufacturer Narrative

D10: medical products: blunt tip screw, 4x38mm; catalog#: 47-2486-038-40; lot#: 3054317, blunt tip screw, 4x38mm; catalog#: 47-2486-038-40; lot#: 3062682, blunt tip screw, 4x40mm; catalog#: 47-2486-040-40; lot#: 3064863, blunt tip screw, 4x42mm; catalog#: 47-2486-042-40; lot#: 3054544, cortical bone screw, 4x24mm; catalog#: 47-2486-124-40; lot#: 3054496, proximal humerus nail cap, 10.5x2.5mm; catalog#: 47-2488-010-02; lot#: 3054395, cortical bone screw, 4x24mm; catalog#: 47-2486-124-40; lot#: 30224294, affixus pr hum corelock drvr; catalog#: 110035663; lot#: unknown torque limiting handle; catalog#: 27923; lot#: unknown.Therapy date: unknown.Review of event description: it was reported that the patient was implanted with zimmer products on (b)(6) 2021.3 weeks post the implantation, it was noticed that the proximal screw got loose and out of the nail, damaging the arm soft tissue.Revision surgery has not been performed yet.Review of received data: due diligence: further due diligence to support the conclusion was completed and documented in diligence log.X-rays: one undated x-ray image was provided for investigation.It shows the proximal end of the nail including four proximal locking screws.However no conspicuous findings relevant to the reported event were identified.Images: one image was received showing the product stickers of the implanted products.However no conspicuous findings relevant to the reported event were identified.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is 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.Raw material certificate: the raw material certificate was reviewed with no anomalies noted.Conclusion: it was reported that the patient was implanted with zimmer products on (b)(6) 2021.3 weeks post the implantation, it was noticed that the proximal screw got loose and out of the nail, damaging the arm soft tissue.Revision surgery has not been performed yet.No product was returned, hence visual and dimensional evaluation could not be performed; therefore, the condition of the parts is unknown.From the available x-ray no conspicuous findings relevant to the reported event were identified.Based on the investigation the reported event cannot be confirmed.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 given information and the results of the investigation, we were not able to identify a specific root cause for this issue.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: BLUNT TIP SCREW, 4X38MM
• 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: 12065236
• MDR Text Key: 263380028
• Report Number: 0009613350-2021-00310
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024505438
• UDI-Public: 00889024505438
• 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: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2486-038-40
• Device Lot Number: 3062682
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization