MAUDE Adverse Event Report: ZIMMER GMBH TI-LOCKING SCREW, SYS2.7, TX8, 12MM; NORMED MEDIZIN-TECHNIK GMBH

Model Number N/A

Device Problem Misassembled (1398)

Patient Problem Failure of Implant (1924)

Event Date 05/15/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.The manufacturer did not receive x-rays, or other source documents for review.The device history records were reviewed and found to be conforming.An e-mail requesting the following additional information was sent on (b)(6) 2018 to the appropriate representatives.It was stated that this information is not 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.(b)(4).

Event Description

It was reported that during a surgery the ti-locking screw, sys2.7, tx8, 12mm did not assemble with the screw driver.A surgical delay of 45 minutes has been reported.Note: the ti-locking screw, sys2.7, tx8, 12mm was not implanted.Therefore the implant/explantation date is left empty.

Manufacturer Narrative

Medical devices: scrdrvr hdl rigid 2/2.3/2.7sys, catalog no# 503004304 ; lot no# unknown.Therapy date : (b)(6) 2018.Additional information was received on june 20, 2018.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).

Manufacturer Narrative

Additional information was received.Additional: if follow-up, what type.Correction: date of report, concomitant medical products, pma/510k, device evaluated by mfr.Concomitant medical devices: scrdrvr hdl rigid 2/2.3/2.7sys, catalog no#: 503004304 ; lot no#: unknown.Scrdrvr-bld tx-lk t8 2.7mm hex, catalog no#: 503004429 ; lot no#: unknown.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).

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Additional: h6 correction: b4 - d10 - g4 - g7 - h2 - h10 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 28.25.012 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 28.25.012 (1 lot 15742, 1 lot unknown) and one from ref 28.25.026.One screw of ref 28.25.012 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 503004288, lot12441/185a13, as the screwdriver blade from ref 503004429 has not been transfered from normed to zimmer biomet.It was found that the torx connection is working as intended and the locking mechnism 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 503004288.The torx connection is working as intended and the locking mechnism 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 503004429 has been fully functional.Based on the given information and the results of the investigation, an exact root caue for the reported event could not be determined.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 cmp-0400253.

Event Description

Please refer to report 0009613350-2018-00636.

• Brand Name: TI-LOCKING SCREW, SYS2.7, TX8, 12MM
• Type of Device: NORMED MEDIZIN-TECHNIK GMBH
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 7609284
• MDR Text Key: 111318445
• Report Number: 0009613350-2018-00636
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK152312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• 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: 15742
• Other Device ID Number: 00889024109216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention