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	07/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: item number 00249003244, item name cephalomedullary lag screw reamer long 3.2 mm i.D., lot # unknown.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
When the surgeon tried to place the lag screw, the tabs fractured due to the dense bone.The patient did not retain a foreign device.
Additional Manufacturer Narrative
Trend analysis: no trend is identified.Event description: during the surgery, the surgeon was unable to easily drill through the bone with the lag screw reamer.The last inch of the instrument fractured in the patient femoral head and was removed without an issue.When the surgeon tried to place the lag screw, the tabs fractured due to the dense bone.The patient did not retain a foreign device.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Devices analysis: visual examination: only the broken cams (2 pieces) were returned for investigation.Based on that parts the reported event can be confirmed.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 when the surgeon tried to place the lag screw, the tabs fractured due to the dense bone.The patient did not retain a foreign device.Onl the lag screw tabs were returned for investigation and based on the visual investigation it can be confirmed that the cams are sheared off.It is assumed that the cams were sheared off during the implantation of the znn nailing system 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).
Event or Problem Description
Investigation results are now available.

• 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: 8919643
• Report Number: 0009613350-2019-00517
• Device Sequence Number: 13929074
• Product Code: HSB
• UDI-Device Identifier: 00889024298477
• UDI-Public: 00889024298477
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-110-10
• Device Lot Number: 2969988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 03/09/2020
• 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: Required Intervention
• Patient Age: 58 YR