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 Device-Device Incompatibility (2919); Appropriate Term/Code Not Available (3191)

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

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: cortical bone screw, 4x32mm, item# 47248613240, lot# 2999923.The manufacturer did not receive x-rays for review.Other source documents were received and 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.(b)(4).

Event Description

During surgery, the implants got stuck and would not move and hence there are possibilities of these screws backing out.After having inserted the proximal screws into the nails when the surgeon tried to the lock the corelock system the screws would not move and were stuck inside the nail.The surgery was completed without fixing the screw with the corelock system.

Manufacturer Narrative

Investigation results were made available.Review of event description: it was reported that operation was performed with ann nail system on (b)(6) 2020.After the proximal screws were inserted into the nail, the surgeon tried to lock the corelock system, but it didn't move and stuck inside the nail.The operation was finished without fixing the screws by the corelock.There is concern that the screws will back out in the future.Review of received data: no medical data relevant to the case has been received.Due diligence: further due diligence to support the conclusion was completed and documented.However, no additional information could be obtained.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.The products remain implanted.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check was performed and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that operation was performed with ann nail system on (b)(6) 2020.After the proximal screws were inserted into the nail, the surgeon tried to lock the corelock system, but it didn't move and stuck inside the nail.The operation was finished without fixing the screws by the corelock.There is concern that the screws will back out in the future.Based on the investigation the reported event cannot be confirmed.As no surgical report has been received, the events leading to the jamming of the corelock cannot be recreated.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 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, 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: 11015117
• MDR Text Key: 222024918
• Report Number: 0009613350-2020-00587
• 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: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 47-2486-046-40
• Device Lot Number: 3024713
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization