MAUDE Adverse Event Report: ZIMMER GMBH ZNN CMN LAG SCREW 10.5 MM, 90 MM, INCLUDING SET SCREW

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/11/2019
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 yet the device, 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.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 the patient was implanted on left side and during revision on the fins of the cephalic screw broke when the surgeon wanted to extract it.It was reported that the surgeon managed to remove it but it took more time than a classic removal and it was necessary to cut a piece of bone around the screw to remove it.
Event or Problem Description
It was reported that the patient was implanted on left side and during revision the fins of the cephalic screw broke when the surgeon wanted to extract it.It was reported that the surgeon managed to remove it but it took more time than a classic removal and it was necessary to cut a piece of bone around the screw to remove it.The surgery was delayed by an hour and the patient was forced to have a revitan stem instead of what was initially planned.
Additional Manufacturer Narrative
Additional information which was received on dec 26, 2019.The manufacturer received x-rays, other source documents (surgical reports) for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).
Event or Problem Description
Investigation done.
Additional Manufacturer Narrative
Investigation results were made available.D11: z nail cpm 11.5mm x 34cm 130 l; ref: (b)(4); lot: 2969311.Event description: it was reported that the patient was implanted on (b)(6) 2019 and during revision on (b)(6) 2019.The fins of the cephalic screw broke when the surgeon wanted to extract it.The surgeon managed to remove it but it took more time than a classic removal and it was necessary to cut a piece of bone around the screw to remove it.Review of received data: the provided x-rays do not show the breakage of the znn lag screw.Devices analysis: visual examination: the lag screw ref (b)(6) lot 2950596 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.Review of product documentation: the involved device is intended for treatment.Surgical technique: the correct lag screw placement is described in the zimmer natural nail system cephalomedullary standard surgical technique.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Conclusion summary: it was reported that the notches of the lag screw were broken during the removal of the znn system and the surgeon had to cut a piece of bone around the screw to remove it.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.It is assumed that the cams were sheared off due to an overload on the cams.Possible causes for the overload could be: unfavorable placement between the instrument and the implant so their contact surface is too small, too high forces will be transmitted on the cams which lead to a fracture of this section.The correct lag screw placement is described in the zimmer natural nail system ¿ cephalomedullary standard surgical technique.Pathogenic bone diseases (e.G.Bone tumor) which can affect mechanical properties of the bone (harder/ denser bone substance).This could also lead to higher forces of these sections.It is mentioned by the surgeon that the tabs fractured due to the dense bone.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).Note: another report for the same patient has been created: (b)(4) / 0009613350-2020-00020.

• Brand Name: ZNN CMN LAG SCREW 10.5 MM, 90 MM, INCLUDING SET SCREW
• Common Device Name: ZNN CMN LAG SCREW
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9529045
• Report Number: 0009613350-2019-00818
• Device Sequence Number: 2703318
• Product Code: HSB
• UDI-Device Identifier: 00889024298439
• UDI-Public: 00889024298439
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-090-10
• Device Lot Number: 2950596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 12/26/2019; 07/02/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 01/10/2020; 07/30/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention