MAUDE Adverse Event Report: ACUMED LLC 3.5MM X 20MM NON-LOCKING HEXALOBE SCREW; SCREW, FIXATION, BONE

Model Number 30-0261

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2020-00065: plate 1.3025141-2020-00066: plate 2.3025141-2020-00067: screw 1.3025141-2020-00068: screw 2.3025141-2020-00070: screw 3.3025141-2020-00071: screw 4.3025141-2020-00072: screw 5.3025141-2020-00073: screw 6.3025141-2020-00074: screw 7.3025141-2020-00075: screw 8.3025141-2020-00076: screw 9.3025141-2020-00077: screw 10.3025141-2020-00078: screw 11.3025141-2020-00079: screw 12.3025141-2020-00080: screw 13.3025141-2020-00081: screw 14.3025141-2020-00082: screw 15.3025141-2020-00083: screw 16.3025141-2020-00084: screw 17.3025141-2020-00085: screw 18.3025141-2020-00086: screw 19.3025141-2020-00087: screw 20.3025141-2020-00088: screw 21.3025141-2020-00089: screw 22.3025141-2020-00090: screw 23.3025141-2020-00091: screw 24.3025141-2020-00092: screw 25.3025141-2020-00094: screw 27.3025141-2020-00095: plate 3.

Event Description

A healthy patient with strong bone was implanted with 2 distal humerus plates, 1 olecranon plate and 27 screws.The patient was casted for six weeks.At the follow up, it was determined that sometime post op, three screws broke, and multiple screws pulled out.All hardware was removed in a revision surgery.

• Brand Name: 3.5MM X 20MM NON-LOCKING HEXALOBE SCREW
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: micki anderson ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 9920268
• MDR Text Key: 186284782
• Report Number: 3025141-2020-00093
• Device Sequence Number: 1
• Product Code: HWC
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 30-0261
• Device Catalogue Number: 30-0261
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 104