MAUDE Adverse Event Report: ZIMMER GMBH ZNN, CMN LAG SCREW, 10.5 MM, 120 MM INCLUDING SET SCREW; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number N/A

Device Problems Failure To Adhere Or Bond (1031); Osseointegration Problem (3003)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 12/30/2015

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices or x-rays 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.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, 120 mm including set screw on (b)(6) 2015.The znn, cmn lag screw was revised on (b)(6) 2015 due to loosening.(same patient is treated in (b)(4)).

Manufacturer Narrative

A technical investigation was not possible to perform, as the devices were not at hand.However, based on the available information the investigation is conducted with outcome as follows.Trend analysis: no trend identified.The dhr check could not be performed as the lot number was not available.The dhr check could not be performed as the lot number was not available.Event summary: it was reported that a znn nailing system was implanted on (b)(6) 2015.On post-op x-ray it was seen that the lag screw was loose.Therefore, the first revision was done on (b)(6) 2015.The second revision of the broken nail is covered in (b)(4).Root cause determination using rmw: lag screw migration due to incorrect lag screw design results into cut out; possible, as no x-rays were sent to check the lag screw position this point cannot be excluded.Wrong definition of implant size due to bone preparation for screw positioning; possible, as no x-rays were sent to check the lag screw position this point cannot be excluded.Wrong positioning of implant due to set screw insertion; possible, it is unknown how the set screw was inserted and if it was inserted correctly.Conclusion summary: neither x-rays nor devices or photos of the explanted implant(s) were received; therefore the condition of the component(s) is unknown.In conclusion, due to significant lack of information, it is impossible to perform a meaningful analysis of the reported event.An exact root cause for the screw loosening could not be determined.The need for corrective actions is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: ZNN, CMN LAG SCREW, 10.5 MM, 120 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: 5754044
• MDR Text Key: 48290714
• Report Number: 0009613350-2016-01008
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-120-10
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2016
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 90