MAUDE Adverse Event Report: ZIMMER GMBH ZNN, CMN LAG SCREW, 10.5 MM, 105 MM INCLUDING SET SCREW; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number	N/A
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer did not receive x-rays but received other source documents for review.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.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
It was reported that during surgery it was found that there was no lag screw inside the package.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: missing component in package event description: it was reported that there was no lag screw inside the packed box.Review of received data: the received photo shows only the label.No statement to the packaging itself can be made.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.No product documentation was reviewed for investigation.Conclusion: it was reported that upon opening the packaging of the znn lag screw, the lag screw was missing.No device has been returned for investigation.The device manufacturing quality records (dhr) indicate that the released components met all requirements to perform as intended.Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The lot tracker showed that no further products are under zimmer biomet control.Therefore no stock investigation could be conducted.Additionally, no further complaint for lot 2913859 has been reported.The investigation results did not identify a non-conformance or a complaint out of box (coob).The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Please refer to report 0009613350 -2019 - 00212.

• Brand Name: ZNN, CMN LAG SCREW, 10.5 MM, 105 MM INCLUDING SET SCREW
• Common Device Name: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8507530
• Report Number: 0009613350-2019-00212
• Device Sequence Number: 13820892
• Product Code: HSB
• UDI-Device Identifier: 00889024298460
• UDI-Public: 00889024298460
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2019

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: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-105-10
• Device Lot Number: 2913859
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 08/23/2019
• 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
• Patient Age: 52 YR