MAUDE Adverse Event Report: ACUMED LLC ACU-LOC OR ACU-LOC 2 DISTAL RADIUS PLATING SYSTEM; PLATE, FIXATION, BONE

Device Problem Fail-Safe Design Failure (1222)

Patient Problem Bone Fracture(s) (1870)

Event Type  malfunction  

Manufacturer Narrative

Additional mdrs associated with this article: 3025141-2018-00028: plate 1, 3025141-2018-00029: plate 2, 3025141-2018-00030: plate 3, 3025141-2018-00031: plate 4, 3025141-2018-00032: plate 5, 3025141-2018-00033: plate 6, 3025141-2018-00034: plate 7, 3025141-2018-00035: plate 8, 3025141-2018-00036: plate 9, 3025141-2018-00037: plate 10, 3025141-2018-00038: plate 11, 3025141-2018-00039: plate 12, 3025141-2018-00040: plate 13, 3025141-2018-00041: plate 14, 3025141-2018-00042: plate 15, 3025141-2018-00043: plate 16, 3025141-2018-00045: plate 18, 3025141-2018-00046: plate 19, 3025141-2018-00047: plate 20, 3025141-2018-00048: plate 21, 3025141-2018-00049: plate 22, 3025141-2018-00050: plate 23, 3025141-2018-00051: plate 24, 3025141-2018-00052: plate 25, 3025141-2018-00053: plate 26, 3025141-2018-00054: plate 27, 3025141-2018-00055: plate 28, 3025141-2018-00056: plate 29, 3025141-2018-00057: plate 30, 3025141-2018-00058: plate 31, 3025141-2018-00059: plate 32, 3025141-2018-00060: plate 33, 3025141-2018-00061: plate 34, 3025141-2018-00062: plate 35, 3025141-2018-00063: plate 36, 3025141-2018-00064: plate 37, 3025141-2018-00065: plate 38, 3025141-2018-00066: plate 39, 3025141-2018-00067: plate 40, 3025141-2018-00068: plate 41, 3025141-2018-00069: plate 42, 3025141-2018-00070: plate 43, 3025141-2018-00071: plate 44, 3025141-2018-00072: plate 45, 3025141-2018-00073: plate 46, 3025141-2018-00074: plate 47, 3025141-2018-00075: plate 48, 3025141-2018-00076: plate 49, 3025141-2018-00077: plate 50, 3025141-2018-00078: plate 51, 3025141-2018-00079: plate 52, 3025141-2018-00080: plate 53, 3025141-2018-00081: plate 54, 3025141-2018-00082: plate 55.

Event Description

Case 17: female.A longitudinal fracture was identified via x-ray with the use of the acu-loc or acu-loc 2 distal radius plating system.Web article: "hairline fractures following volar plating of the distal radius: a recently recognized hardware-related complication".Skeletal radiology (https://doi.Org/10.1007/s00256-018-2877-9).Published on line 2018/01/22."abstract objectives: intraoperative hairline longitudinal fractures were recently reported in association with distal radius volar plating.Our aim was to further analyze this newly described complication.Methods: a retrospective radiographic and chart review was performed on 225 patients who underwent distal radius plating between june 2013 and june 2015.The acu-loc/acu-loc2© plating system (acumed, (b)(4), usa) was used in 208 cases, and the variax© plating system (stryker, (b)(4), usa) was used in 17 cases.Three independent reviewers performed a blind evaluation of all relevant radiographs for the occurrence of longitudinal fractures around the plate, and validity was considered only when there was agreement among all three of them.Results: hairline longitudinal fractures were identified in 57 cases (25%), 55 with the acu-loc/acu-loc2© system and 2 with the variax© system.All fractures occurred with volar plating.Fracture occurrence was associated with age over 59 years, female gender, extra-articular fractures, and the use of hexalobe screws (acu-loc/acu-loc2© system).Conclusions: we believe that the source of fracture occurrence lies within the screw design and that better screw design and possibly tapping in patients at risk may reduce the occurrence of intraoperative hairline longitudinal fractures.Further clinical and biomechanical research is needed to better understand this newly reported complication.".

• Brand Name: ACU-LOC OR ACU-LOC 2 DISTAL RADIUS PLATING SYSTEM
• Type of Device: PLATE, 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 lehman ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 7232128
• MDR Text Key: 99085978
• Report Number: 3025141-2018-00044
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012655
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2018
• 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