MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X44MM; AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395)

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

Event Date 06/25/2021

Event Type  Injury  

Manufacturer Narrative

Medical product: blunt tip screw, 4x65mm; item#47248606540; lot#3010693; blunt tip screw, 4x38mm; item#47248603840; lot#3064862; blunt tip screw, 4x36mm; item#47248603640; lot#3068457; proximal humerus, right, 11x160mm; item#47249616011; lot#3045138 cortical bone screw, 4x26mm; item# 47248612640; lot#3054456; cortical bone screw, 4x28mm; item#47248612840; lot#3054458; proximal humerus nail cap, 0mm; item#47248801000; lot#3073821 the manufacturer did not received x-rays or any other source documents for review.Lot numbers were received and the device history record were reviewed and found to be conforming.The investigation of the case and the process of gaining necessary information is still ongoing.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

During the surgery, it was noticed by the surgeon that the screw was loose and couldn't be tightened.

Event Description

No event update.Investigation results were made available.

Manufacturer Narrative

1.Review of event description: it was reported that during an initial surgery with ann nail system on (b)(6) 2021, it was reported that while fixing the proximal screws with the corelock it was observed that the screws were able to move with three fingers.The surgeon couldn't tighten the screw with torque driver hence surgeon tried to tighten the screw with non-torque driver but could not fix the screws.Hence the surgery was completed with the same condition.2.Review of received data: - due diligence: further "due diligence" to support the conclusion was completed.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 review shows a non-conformity for ref (b)(4), lot 3045138.Nevertheless, the parts were released into production processes and further manufacturing of the implants was completed without any further deviations.- 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 during an initial surgery with ann nail system on (b)(6) , 2021, it was reported that while fixing the proximal screws with the corelock it was observed that the screws were able to move with three fingers.The surgeon couldn't tighten the screw with torque driver hence surgeon tried to tighten the screw with non-torque driver but could not fix the screws.Hence the surgery was completed with the same condition.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.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 non-fixation of the screw might be multifactorial related to either 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: BLUNT TIP SCREW, 4X44MM
• 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: 12249253
• MDR Text Key: 266169558
• Report Number: 0009613350-2021-00357
• Device Sequence Number: 1
• Product Code: HSB
• 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: 09/23/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47-2486-044-40
• Device Lot Number: 3010652
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/29/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA 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