MAUDE Adverse Event Report: ZIMMER GMBH ZNN, CMN LAG SCREW, 10.5 MM, 110 MM INCLUDING SET 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	05/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer did not receive x-rays, or 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.Attempts to obtain additional information have been made; however, no more is 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 while removing the titanium cervical screw from the nail, the vanes of the screw broke making it difficult to remove.Surgery was extended of 20 minutes.
Event or Problem Description
Please refer to report 0009613350-2019-00439.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: additional: h2 - h6.Correction: b4 - d10 - g4 - g7 - h10.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend has been identified.Event description: it was reported that the notches of the lag screw were broken during the removal of the znn system.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Device analysis: visual examination: the lag screw ref 47-2485-110-10 lot 2828301 was returned for investigation.The visual examination shows that the lag screw tabs/notches were broken.The broken pieces have not been returned.In addition, there are circular marks visible on shaft area of the lag screw.This can be caused during the implantation or while trying to remove the lag screw.No other deformations or damages can be seen.Review of product documentation: the involved device is intended for treatment.Surgical technique: the correct lag screw removal is described in the zimmer natural nail system ¿ cephalomedullary standard surgical technique.Conclusion: it was reported that the notches of the lag screw were broken during the removal of the znn system.The lag screw was returned for investigation.The breakage of the lag screw tabs/notches can be confirmed.The correct lag screw removal is described in the zimmer natural nail system ¿ cephalomedullary standard surgical technique 97-2493-002-00.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 removal 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.Excessive bone ingrowth onto the lag screw due to long in vivo time of the implant system, which makes high forces needed to remove the screw in a removal case.The in vivo time was approx.2.5 years.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).

• Brand Name: ZNN, CMN LAG SCREW, 10.5 MM, 110 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: 8779506
• Report Number: 0009613350-2019-00439
• Device Sequence Number: 2665927
• Product Code: HSB
• UDI-Device Identifier: 00889024298477
• UDI-Public: 00889024298477
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-110-10
• Device Lot Number: 2828301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 02/28/2020
• 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: 43 YR
• Patient Weight: 75