MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, LONG, 8.5X220MM; AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number N/A

Device Problems Mechanical Problem (1384); Migration (4003)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Medical product: blunt tip screw, 4x34mm; item# : 47248603440; lot# : 3010625; blunt tip screw, 4x44mm; item# : 47248604440; lot# : 3024701; blunt tip screw, 4x46mm; item# : 47248604640; lot# : 3024713; cortical bone screw, 4x22mm; item# : 47248612240; lot# : 3054244; cortical bone screw, 4x22mm; item# : 47248612240; lot# : 3054448; proximal humerus nail cap, 0mm; item# : 47248801000; lot# : 3054381.The manufacturer did not receive x-rays for review.Other source documents were received and will be reviewed as part of ongoing investigation.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.After 2 months from initial surgery, the surgeon observed that the 3rd screw of the proximal screws backed out from the implanted position.The surgeon keeps monitoring the patient condition.No revision surgery is planned so far.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.D10: medical products: torque limiting handle; catalog#: 27923; lot#: unknown.Lg cann screwdriver handle; catalog#: 214149000; lot#: unknown.Therapy date: unknown.Additional information was received on jul 21, 2021.The manufacturer received other source documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

Patient was implanted with ann nail system on an unknown side.Two months from the initial surgery the surgeon noticed that the third proximal screw had backed out from its position.The surgeon is monitoring the patient's condition and a revision surgery has not yet been planned.The torque driver was used to engage the corelock, furthermore non-torque driver was used to tighten more after using the torque driver.

Event Description

No event update.Investigation results are now available.

Manufacturer Narrative

Investigation results were made available.Additional: h2, h6.Correction: b4, b5, g3, g6, h10.1.Review of event description: - it was reported that the patient was implanted with ann nail on (b)(6) 2021.After 2 months from initial surgery, the surgeon observed that the 3rd screw of the proximal screws was backed out from the implanted position.The surgeon keeps monitoring the patient condition.No revision surgery is planned so far.Harm: s2 - instability, minor.Hazardous situation: loss of fixation or non-integration of an implant.2.Review of received data: - patient was implanted with ann nail on (b)(6) 2021.After 2 months from initial surgery, the surgeon observed that the 3rd screw of the proximal screws was backed out from the implanted position.The surgeon keeps monitoring the patient condition.No revision surgery is planned so far.3.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.4.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.Surgical technique sap: the surgical technique 197-glbl-en explains that the locking of the corelock is done using the corelock driver with torque limiting handle."turn slowly clockwise to tighten and engage the corelock mechanism until a click is felt from the torque limiting handle." 5.Conclusion: it was reported that the patient was implanted with ann nail on may 6, 2021.After 2 months from initial surgery, the surgeon observed that the 3rd screw of the proximal screws was backed out from the implanted position.The surgeon keeps monitoring the patient condition.No revision surgery is planned so far.Neither x-rays, operative notes, office visit notes, nor devices or photos of the devices were received; therefore the condition of the components is unknown.Patient factors that may have affected the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.The locking of the corelock during the initial surgery has not been performed as specified in the surgical technique using only the corelock driver with torque limiting handle.Instead, additionally a non-torque limiting screwdriver was used.It remains unknown what the potential effect of this deviation from the surgical technique could be.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 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 behaviour, 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.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).

• Brand Name: PROXIMAL HUMERUS, RIGHT, LONG, 8.5X220MM
• 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: 12275304
• MDR Text Key: 265126327
• Report Number: 0009613350-2021-00384
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024505902
• UDI-Public: 00889024505902
• 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,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• 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: 47-2496-220-08
• Device Lot Number: 3031577
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention