MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ZNN, CMN LAG SCREW, 10.5 MM, 80 MM, INCLUDING SET SCREW; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer received other source documents for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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 Description

During surgery it was noticed by the surgeon that the set screw was stuck and could not be moved in any direction.Product remains implanted in the patient.The whole procedure was delayed by 60 minutes.

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that during the surgery it was noticed by the surgeon that the set screw was stuck and couldn't be turned.And later the surgeon couldn't even move the set screw back and forth.There was a delay over 60 mins.Eventually surgeon gave up to fix a lag screw with the set screw.Product remains implanted in the patient.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Surgical technique: the insertion of the set screw is described in the surgical technique on page 20 and 21.A set screw (included in the lag screw package or packaged separately) must be used to prevent the lag screw from rotating post-operatively.Conclusion: it was reported that during the surgery it was noticed by the surgeon that the set screw was stuck and couldn't be turned.And later the surgeon couldn't even move the set screw back and forth.There was a delay over 60 mins.Eventually surgeon gave up to fix a lag screw with the set screw.Product remains implanted in the patient.The insertion of the set screw is described in the surgical technique on page 20 and 21.A set screw (included in the lag screw package or packaged separately) must be used to prevent the lag screw from rotating post-operatively.The set screw should be tightened down into the groove in the lag screw.As noted above, the lag screw inserter must be positioned so that the handle on the inserter is parallel or perpendicular to the colored dots on the targeting guide in order for the set screw and lag screw grooves to engage properly.To verify engagement, attempt to twist the lag screw inserter.If it cannot be rotated using a reasonable amount of force, the construct is in the correct position.If rotation is possible, adjust the position of the lag screw (rotate slightly) so that the set screw can enter the groove in the lag screw.The product was not received for investigation.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).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).The following reports are associated with this event: 0009613350-2020-00403, 0009613350-2020-00404.

Event Description

During surgery it was noticed by the surgeon that the set screw was stuck and could not be moved in any direction.Product remains implanted in the patient.The whole procedure was delayed by 60 minutes.

Manufacturer Narrative

Additional information which was received on (b)(6) 2020.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additionals: e1.Corrections: b4, g4, g7, h2, h10.The manufacturer did not receive documents for review.Should any additional information become available or 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).

• Brand Name: ZNN, CMN LAG SCREW, 10.5 MM, 80 MM, INCLUDING SET SCREW
• Type of Device: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10527500
• MDR Text Key: 206748818
• Report Number: 0009613350-2020-00404
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024298415
• UDI-Public: 00889024298415
• Combination Product (y/n): N
• PMA/PMN Number: K091566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-080-10
• Device Lot Number: 3015151
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization