MAUDE Adverse Event Report: STRYKER GMBH 5.0MM CABLE PLUG AXSOS 3 TI; PLATE, FIXATION, BONE

Model Number 661002S

Device Problem Material Deformation (2976)

Patient Problem Failure of Implant (1924)

Event Date 03/21/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.

Event Description

The customer reported to sales rep that : " on (b)(6), the surgeon placed 2 dall-miles 6704-0-510, 3 plugs 661002s and an axsos titanium plate 627573s on a total hip prosthetic fracture.On (b)(6), the patient was taken back: the plugs were not adapted: broken? or open? " sales rep said : "an incident following an axsos plate installation with dall miles plugs and strapping cables.The plugs are deformed and the cable broke." additional information: the dall-miles cable did not break, but was intentionally cut by the surgeon during removal.

Manufacturer Narrative

D9 / h3 updated with product return information.The reported event could be confirmed, since the received cable plug is deformed as complained.The device inspection revealed the following: the inspection has shown that the cable plug is expanded.There is a deep scratch on one side of the slot visible.The edges that hold the plug in the plate are on both sides intact.Next to the deep scratch are also strong stress marks at the edge on the same side of the slot visible.These marks indicate that the cable slipped out from the plug on this side.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on the provided information the exact root cause of this occurrence can not be defined, for this all involved devices and x-rays would be needed.However, based on investigation findings of the returned parts, the root cause was attributed to a user related issue.The visible damages at one side of the plug slot indicate that the cable slipped out from the plug on this side.This finding and the above described intact edges are an indication that the plug was inserted in an oblong hole instead of an universal hole.Due to this the lateral fixation of the plug was not given and the cable could slip out and lead to the deformation/expanding of the plug.In this relation the operative technique the following statement can be pointed out: ¿[when used with the broad or narrow axsos 3 titanium waisted compression plates, only use the cable plug in the universal holes and not oblong compression holes of the plates.]" [original statement] if more information is provided, the case will be reassessed.

Event Description

The customer reported to sales rep that : " on (b)(6), the surgeon placed 2 dall-miles 6704-0-510, 3 plugs 661002s and an axsos titanium plate 627573s on a total hip prosthetic fracture.On (b)(6), the patient was taken back: the plugs were not adapted: broken? or open? " sales rep said : "an incident following an axsos plate installation with dall miles plugs and strapping cables.The plugs are deformed and the cable broke." additional information: the dall-miles cable did not break, but was intentionally cut by the surgeon during removal.

• Brand Name: 5.0MM CABLE PLUG AXSOS 3 TI
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 12127889
• MDR Text Key: 260246871
• Report Number: 0008031020-2021-00290
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327283723
• UDI-Public: 07613327283723
• Combination Product (y/n): N
• PMA/PMN Number: K172350
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 661002S
• Device Catalogue Number: 661002S
• Device Lot Number: G23101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Date Manufacturer Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 67