MAUDE Adverse Event Report: ACUMED LLC LOW PROF CLAVICLE PLATE, 8-HOLE STR LEF; PLATE, FIXATION, BONE

Model Number 70-0286

Device Problems Sticking (1597); Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 09/18/2017

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2017-00244: screw.

Event Description

When inserting the most medial screw into a clavicle plate, the screw was binding in the plate and could not be fully seated into the plate.Several other screws were attempted, wih the same outcome.There was a more than 30 minute delay in the surgery.

• Brand Name: LOW PROF CLAVICLE PLATE, 8-HOLE STR LEF
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 9432
• Manufacturer (Section G): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124 9432
• Manufacturer Contact: micki lehman ; 5885 nw cornelius pass road; hillsboro, OR 97124-9432 ; 8886279957
• MDR Report Key: 6931422
• MDR Text Key: 89172937
• Report Number: 3025141-2017-00243
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 70-0286
• Device Catalogue Number: 70-0286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 20 YR