MAUDE Adverse Event Report: STRYKER GMBH LOCKING COMPRESSION PLATE AXSOS 3 TI 9 HOLE / L123MM 4.0MM LOCKING; PLATE, FIXATION, BONE

Catalog Number 627509

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Date 10/10/2018

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that patient's left humerus was revised due to a broken plate.Surgeon reported patient had suffered two falls prior to revision.The plate and 7 screws were revised to an axsos 5.0 broad compression plate.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

Manufacturer Narrative

The reported event that locking compression plate axsos 3 ti 9 hole / l123mm 4.0mm locking was alleged of 'implant breakage after surgery' could be confirmed.Based on investigation, the root cause was attributed to be patient related.The failure was caused by the falls that the patient had.Indeed, the implant is not supposed to withstand forces related to important shocks.The device inspection revealed the following: the plate was returned, and is indeed broken at the level of the fifth hole.When put together, the two pieces show that the plate was severely bent, probably caused by one of the falls.The analysis of the breakage surface shows very clear breakage lines, and a large tear-off surface.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.If any further information is provided, the investigation report will be updated.

Event Description

It was reported that patient's left humerus was revised due to a broken plate.Surgeon reported patient had suffered two falls prior to revision.The plate and 7 screws were revised to an axsos 5.0 broad compression plate.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

• Brand Name: LOCKING COMPRESSION PLATE AXSOS 3 TI 9 HOLE / L123MM 4.0MM LOCKING
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8039721
• MDR Text Key: 126218278
• Report Number: 0008031020-2018-00944
• Device Sequence Number: 0
• Product Code: HRS
• PMA/PMN Number: K162439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

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 Catalogue Number: 627509
• Device Lot Number: L47011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Initial Date Manufacturer Received: 10/10/2018
• Initial Date FDA Received: 11/05/2018
• Supplement Dates Manufacturer Received: 12/19/2018
• Supplement Dates FDA Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 109