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 march 21, 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 june 7, 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.

Event Description

The customer reported to sales rep that : " on march 21, 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 june 7, 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

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• 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: 12127878
• MDR Text Key: 260245065
• Report Number: 0008031020-2021-00289
• 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: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 07/07/2021
• Supplement Dates Manufacturer Received: 07/28/2021
• Supplement Dates FDA Received: 08/18/2021
• 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