MAUDE Adverse Event Report: ZIMMER GMBH TI-LOCKING SCREW, SYS2.7, TX8, 12MM; RECON SYSTEM-V-TEK-IVP PLATES AND SCREWS

Model Number N/A

Device Problem Misassembled (1398)

Patient Problem Failure of Implant (1924)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products and therapy date detail of product: item # 2825012, item name ti-locking screw, sys2.7, tx8, 12mm, lot / software release # (b)(4).Item # 503004429, item name scrdrvr-bld tx-lk t8 2.7mm hex, lot # unknown.Item # 2825026, item name ti-locking screw, sys2.7, tx8, 26mm, lot # unknown.This follow-up report is being filled to relay initial report combined with investigation result.Dhr review: as no lot number was provided, the device history records could not be reviewed.Trend analysis: no trend considering the following event is identified: assembly issue.Event description: it was reported that screwdriver blade does not hold the torx connection of the screws.One screw of ref (b)(4) and lot 15742 has been initially reported.Review of received data: one picture of the screwdriver blade has been received.However, the lot remains unknown.One video has been received, demonstrating that one screw could not be picked up with the screwdriver blade, whereas it worked for another screw.Device analysis: visual examination: three screws have been returned for an investigation.Two have been of ref (b)(4) (1 lot 15742, 1 lot unknown) and one from ref (b)(4).One screw of ref (b)(4) has a slightly and one a heavily deformed and damaged torx connection.It cannot be determined whether it is the screw of lot 15742 or of the unknown lot.The other two screws are not damaged.A functional check of the torx connection of each screw was performed.The torx function was inspected with a screwdriver blade ref (b)(4), lot 12441/185a13, as the screwdriver blade from ref (b)(4) has not been transferred from normed to zimmer biomet.It was found that the torx connection is working as intended and the locking mechanism was also given for each screw.No issue found with the torx connection of the screws.Review of product documentation: no product documentation was reviewed for investigation.Root cause analysis: root cause determination using sap rmw: device not ready to be used due to chemical / galvanic / crevice corrosion of material, discolouration not possible -> no corrosion found on the returned devices.Plates/screws/instruments does not mate with components due to lack of adequate design of mating components not possible -> a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.Instrument/part does not fit to compatible components due to wrong design of instrument connection not possible -> a systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.Deterioration in function due to wrong, inadequate maintenance => possible, it is unknown if the correct maintenance of the used screwdriver for the screws was done.Dysfunctionality / malfunction of defective devices and instruments due to mishandling of device by user => possible, as it is unknown whether the user did use the screwdriver and the screws correctly.One torx connection is damaged.Wrong product selection due to misinterpretation of product information, inaccurate device selection => possible, it is unknown how the screws were used.The investigation did not show any issue.Conclusion: it was reported that the screws cannot be connected to the screwdriver blade.Three screws have been returned for an investigation.A functional check of the torx connection of each screw was performed with a screwdriver blade of ref (b)(4).The torx connection is working as intended and the locking mechanism was also given for each screw.No issue found with the torx connection of the screws.However it remains unknown, if the used screwdriver blade of ref (b)(4) has been fully functional.Based on the given information and the results of the investigation, an exact root cause for the reported event could not be determined.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

Event Description

It was reported that during a surgery the screw was not matching with the screwdriver because not able to plug the locking pin.

• Brand Name: TI-LOCKING SCREW, SYS2.7, TX8, 12MM
• Type of Device: RECON SYSTEM-V-TEK-IVP PLATES AND SCREWS
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8077216
• MDR Text Key: 127341301
• Report Number: 0009613350-2018-01151
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K152312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 28.25.012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other