MAUDE Adverse Event Report: ACUMED LLC LKG MTP/MPJ COMBO PLATE, R; PLATE, FIXATION, BONE

Model Number 70-0037

Device Problem Sticking (1597)

Patient Problem No Code Available (3191)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

Additional mdrs associated with this event: 3025141-2017-00336: drill guide.

Event Description

During implantation of a mid foot plate, the drill guide got stuck in the plate in-situ.The plate, with the guide still attached, was removed and another plate was implanted.There was a 45 minute delay in surgery time.

• Brand Name: LKG MTP/MPJ COMBO PLATE, R
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 nw cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: micki lehman ; 5885 nw cornelius pass road; hillsboro, OR 97124 ; 8886279957
• MDR Report Key: 7140404
• MDR Text Key: 95853330
• Report Number: 3025141-2017-00335
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 70-0037
• Device Catalogue Number: 70-0037
• Device Lot Number: 424575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2017
• Date Device Manufactured: 10/18/2017
• 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: 62 YR