MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, 11X160MM; AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number	N/A
Medical Device Problem Codes	Mechanical Problem (1384); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical product: blunt tip screw, 4x36mm; item# : 47248603640; lot# : 3068457.Blunt tip screw, 4x38mm; item# : 47248603840; lot# : 3064862.Blunt tip screw, 4x44mm; item# : 47248604440; lot# : 3010652.Blunt tip screw, 4x65mm; item# : 47248606540; lot# : 3010693.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 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 or Problem Description
During an initial surgery, 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.
Event or Problem Description
No event update.Investigation results are now available.
Additional Manufacturer Narrative
Investigation results were made available.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.Review of received data: due diligence: further "due diligence" to support the conclusion was completed and documented in diligence log.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.Ncr(s): for 61 parts a concession was made due to dimensions out of specification.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." 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: PROXIMAL HUMERUS, RIGHT, 11X160MM
• 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: 12249191
• Report Number: 0009613350-2021-00359
• Device Sequence Number: 14412763
• Product Code: HSB
• UDI-Device Identifier: 00889024505797
• UDI-Public: 00889024505797
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2496-160-11
• Device Lot Number: 3045138
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 09/23/2021
• 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