MAUDE Adverse Event Report: ZIMMER GMBH ZNN, CMN LAG SCREW, 10.5 MM, 85 MM, INCLUDING SET SCREW; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 11/13/2014

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review.As no lot numbers were provided for the devices, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.Additional information has been requested and is not currently available.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.(b)(4).

Event Description

It was reported that the patient was implanted a znn, cmn lag screw, 10.5 mm, 85 mm, including set screw on (b)(6) 2014.The patient was revised on (b)(6) 2014 due to pain.The surgeon¿s aware date was (b)(6) 2014 and he diagnosed the patient¿s condition as cut out of lag screw.Then the surgeon evaluated that the relationship between this serious adverse event and the device is uncertain.

Manufacturer Narrative

Trend analysis: no trend identified.Device history records (dhr): the dhr check could not be performed as the lot number was not available.Event summary: a cut out of the lag screw was reported.Review of received data: in total 4 x-ray pictures were received.Two pre operative x-rays ((b)(6) 2014) and two post operative x-rays ((b)(6) 2014).A bone breakage is visible on the pre operative pictures.The post operative pictures show an implanted znn nailing system.The use of a set screw to avoid the lag screw rotating post-operatively cannot be seen.It is unknown if a set screw was used in the surgery.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: the surgical technique describes the following: "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.To achieve sliding, tighten the set screw and then rotate the set screw inserter counter clockwise one quarter turn.Do not unscrew the set screw more than one quarter turn.Do not over tighten the lag screw.The distal edge must protrude laterally through the femur to ensure that sliding can occur." root cause determination using rmw: lag screw migration due to incorrect lag screw design results into cut out: not possible -> a systematic issue with design and/or material properties would have been detected as part of a trend review defined in complaint registration, systematic assessment defined in complaint investigation or in the current pms process post market surveillance.Failure of surgery due to use of the device not compliant with defined indications: not possible -> the znn system was used for a defined indication.Failure of surgery due to wrong selection of components or use in combination with device outside the znn cmn system => possible, the use of a set screw cannot be seen on the provided post op x-rays.It is unknown if a set screw was placed or not.Conclusion summary: it was reported that there was a cut out of the lag screw.On the provided x-rays it cannot be seen that a set screw was used.The surgical technique describes all the steps as mentioned above.However, an exact root cause for the cut out could not be determined.The need for further corrective measures is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: ZNN, CMN LAG SCREW, 10.5 MM, 85 MM, INCLUDING SET SCREW
• Type of Device: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6188618
• MDR Text Key: 62839546
• Report Number: 0009613350-2016-01464
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• 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: 47-2485-085-10
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 42