MAUDE Adverse Event Report: ACUMED LLC 2.3MM X 24MM NON-TOGGLING CORTICAL SCREW; SCREW, FIXATION, BONE

Model Number CO-N2324

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Type  Injury  

Manufacturer Narrative

The returned screw was examined under magnification.No evidence of non-normal wear was present.As this screw did not interface with other implants in this case, deformation of the screw was limited to the recess, as a result of screw insertion.No deficiency was found.Additional mdrs associated with this event: 3025141-2017-00100: plate, 3025141-2017-00101: screw 1, 3025141-2017-00102: screw 2, 3025141-2017-00103: screw 3, 3025141-2017-00104: screw 4, 3025141-2017-00105: screw 5, 3025141-2017-00106: screw 6, 3025141-2017-00107: screw 7.

Event Description

A clavicle plate was implanted on (b)(6) 2017.The patient fell while skateboarding.One of the screws broke; the plate and the screws were explanted on (b)(6) 2017.

• Brand Name: 2.3MM X 24MM NON-TOGGLING CORTICAL SCREW
• Type of Device: SCREW, 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
• MDR Report Key: 6609564
• MDR Text Key: 76590750
• Report Number: 3025141-2017-00108
• 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: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: CO-N2324
• Device Catalogue Number: CO-N2324
• Device Lot Number: 383677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2016
• 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: 29 YR