MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CORTICAL BONE SCREW, 4X26MM; AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL

Model Number	N/A
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer received photographs which will be reviewed as part of ongoing investigation.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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
It was reported that operation was performed with ann system.During the procedure the surgeon noticed discrepancies between length of the screw which he wanted to implant the label and the engraving on the screw.Label and engraving was the same but the effective length of the screw was different.
Additional Manufacturer Narrative
Investigation results were made available.1.Event description: it was reported that an operation was performed with ann system on (b)(6) 2021.During the procedure, surgeon choose a screw which length is 26mm and he implanted it but he felt uncomfortable of the length.Then, he explanted it and he measured the screw length, it was 30mm.Label says the screw length is 26mm and the engraving on the screw is 26 mm.However the implant length is 30mm.The operation was completed with a backup screw and no issues of the patient were reported.Harm: s1 - no patient, user, or other stakeholder harm hazardous situation: packaging: wrong device(s) in packaging.2.Review of received data: - no medical data relevant to the case has been received.- due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.- images: the received images were reviewed and confirm the reported event.The he affixus cortical bone screw was labeled and lasermarked as size 26 mm but physically measured 30 mm length.3.Product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.However, the received images were sufficient.4.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: select product compatibility - dhr review: the review showed that the products are manufactured and laser marked by the supplier diener ag (sap #503570).Zb received 197 devices of semi-finished item ref.(b)(4) ann cort.Screw ø4 x 26mm and distributed this into two zb batches (3073812 and 3073813).5.Conclusion: it was reported that an operation was performed with ann system on (b)(6) 2021.During the procedure, surgeon choose a screw which length is 26mm and he implanted it but he felt uncomfortable of the length.Then, he explanted it and he measured the screw length, it was 30mm.Label says the screw length is 26mm and the engraving on the screw is 26 mm.However the implant length is 30mm.The operation was completed with a backup screw and no issues of the patient were reported.The received images were reviewed showed that the affixus cortical bone screw was labeled and lasermarked as size 26 mm but physically measured 30 mm length.Manufacturing documentation showed that the screws are manufactured and laser marked by the supplier.Based on the investigation the reported event can be confirmed.The investigation did identify a nonconformance or a complaint out of box (coob).Based on the given information and the results of the investigation, we identified the root cause to be a manufacturing issue at the supplier.Appropriate corrective and preventive actions were initiated at the supplier and are ongoing (scar-03321).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 or Problem Description
Investigation results are now available.

• Brand Name: CORTICAL BONE SCREW, 4X26MM
• Common Device Name: AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12859768
• Report Number: 0009613350-2021-00599
• Device Sequence Number: 4093586
• Product Code: HSB
• UDI-Device Identifier: 00889024505339
• UDI-Public: 00889024505339
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181827
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/28/2021

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: Health Professional
• Device Expiration Date: 05/19/2026
• Device Model Number: N/A
• Device Catalogue Number: 47-2486-126-40
• Device Lot Number: 3073813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 12/27/2021
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Sex: Female