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

Model Number 661002S

Device Problem Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device remains in the patient.

Event Description

The stryker sales rep reported that the surgeon was using an axsos iii cable plug and a non-stryker beaded wire.As he was feeding the wire through the cp plate the surgeon did not have a single sided tensioner and as such he couldn't get tension quickly.The cable plug fell out into the patient.The device fell near the proximal femur, close to the plate and could not be located, so the surgeon chose to leave it in the patient.The case was completed but there was an 8 minute delay to surgery.The surgeon had checked the kit prior to the case and was aware in advance of the case that the config did not carry a single sided tensioner.

Manufacturer Narrative

The reported event that 5.0mm cable plug axsos 3 ti was alleged of 'known misuse reported by the user' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Based on investigation, the root cause was attributed to be user related.The failure was caused by misuse of the product, since the adequate instruments were not all present in the operating room.Indeed, it is clealy stated in the event description that: " [.] as he was feeding the wire through the cp plate the surgeon did not have a single sided tensioner and as such he couldn't get tension quickly.The cable plug fell out into the patient.[.] ".It is the responsability of the hcp to ensure that all the required instruments are present in the operating room prior to surgery.As a reminder, the ifu states: "[.] pre-operative ¿ ensure that all components needed for the operation are available in the operation theatre.[.] " 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.

Event Description

The stryker sales rep reported that the surgeon was using an axsos iii cable plug and a non-stryker beaded wire.As he was feeding the wire through the cp plate the surgeon did not have a single sided tensioner and as such he couldn't get tension quickly.The cable plug fell out into the patient.The device fell near the proximal femur, close to the plate and could not be located, so the surgeon chose to leave it in the patient.The case was completed but there was an 8 minute delay to surgery the surgeon had checked the kit prior to the case and was aware in advance of the case that the config did not carry a single sided tensioner.

• 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 ; CH 2545
• MDR Report Key: 7462966
• MDR Text Key: 107088976
• Report Number: 0008031020-2018-00324
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327283723
• UDI-Public: (01)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: company representative
• Type of Report: Initial,Followup
• Report Date: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other