MAUDE Adverse Event Report: ZIMMER GMBH Z NAIL 10.5 X 105 LAG SCREW; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
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.(b)(4).
Event or Problem Description
It was reported that the set screw would not properly engage lag screw.The lag screw tabs were broken off lag screw.However it was implanted on the left side of the hip.
Event or Problem Description
Please refer to report 0009613350-2019-00143-1.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.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: lag screw tabs broken.Event description: it was reported that the user had difficulties to insert the set screw.In addition the lag screw tabs were broken off.It was implanted on the left side of the hip.The broken tabs on the lag screw were still attached to the implanted lag screw and could not be extracted.The set screw was ultimately implanted.The surgery could be successfully completed.Review of received data: two x-rays have been received.The broken lag screw tabs can be seen on the x-rays.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.Surgical technique: the implantation of the lag screw is described in the zimmer natural nail system ¿ cephalomedullary standard surgical technique.Conclusion: it was reported that the user had difficulties to insert the set screw.In addition the lag screw tabs were broken off.It was implanted on the left side of the hip.The broken tabs on the lag screw were still attached to the implanted lag screw and could not be extracted.The set screw was ultimately implanted.The surgery could be successfully completed.From the received pictures (x-rays), the breakage of the lag screw tabs can be confirmed.The damaged (broken) lag screw tabs have not been removed and are still in patient's body.The correct implantation of the lag screw is described in the zimmer natural nail system ¿ cephalomedullary standard surgical technique 97-2493-002-00.To remove the lag screw with broken tabs, the cephalomedullary lag screw extraction device (ref 00-2490-090-12) can be used.The investigation results did not identify a non-conformance or a complaint out of box (coob).There are possible causes for the breakage of the lag screw tabs during the implantation of the znn nailing system: if the contact surface of the instrument and implant is too small, too high forces will be transmitted on the cams which lead to a fracture of this section.Pathogenic bone diseases (e.G.Bone tumor) which affect mechanical properties of the bone (harder/ denser bone substance).However, based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.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).
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additional and corrected information are filled in the following fields: 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
In addition to report , the broken tabs on the lag screw were still attached to the implanted lag screw and could not be extracted.

• Brand Name: Z NAIL 10.5 X 105 LAG 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: 8427127
• Report Number: 0009613350-2019-00143
• Device Sequence Number: 14015586
• Product Code: HSB
• UDI-Device Identifier: 00889024298460
• UDI-Public: 00889024298460
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2019

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: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-105-10
• Device Lot Number: 2940285
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 04/12/2019; 09/26/2019
• Initial Report FDA Received Date: 03/16/2019
• Supplement Report FDA Received Date: 04/16/2019; 09/30/2019
• 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