MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL LATERAL HUMERUS PLATE TS AXSOS FOR LEFT HUMERUS 10 HOLE, L176MM; PLATE, FIXATION, BONE

Catalog Number 437110S

Device Problem Bent (1059)

Patient Problem Fall (1848)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported: "revision scheduled for friday (b)(6) 2018.Patient is said to have fallen and that's why the plate bent/ failed." rep provided an x-ray provided to her on (b)(6) 2018.Left side.

Manufacturer Narrative

The reported event that proximal lateral humerus plate ts axsos for left humerus 10 hole, l176mm was alleged of 'device deformed' could be confirmed.Based on investigation, the root cause was attributed to be patient related.The failure was caused due to a fall of the patient.The device inspection revealed the following: it is clearly evident that the returned revised proximal lateral humerus plate is indeed badly bent / deformed.Which is surely the result of the patient fall (as reported).Screws were still intact though.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

As reported: "revision scheduled for friday (b)(6) 2018.Patient is said to have fallen and that's why the plate bent/ failed." rep provided an x-ray provided to her on (b)(6) 2018.Left side.

• Brand Name: PROXIMAL LATERAL HUMERUS PLATE TS AXSOS FOR LEFT HUMERUS 10 HOLE, L176MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7294123
• MDR Text Key: 100885402
• Report Number: 0008031020-2018-00135
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2018
• Device Catalogue Number: 437110S
• Device Lot Number: R28981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/23/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR