MAUDE Adverse Event Report: STRYKER GMBH CROSS PLATE LAPIDUS STEP, RT ANCHORAGE; PLATE, FIXATION, BONE

Catalog Number PLP29372S

Device Problems Misconnection (1399); Difficult to Advance (2920)

Patient Problem No Information (3190)

Event Date 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Disposition unknown.

Event Description

Issue with screw head going through the plates and not engaging.

Manufacturer Narrative

This device is concomitant and did not contribute to the reported failure.This investigation is therefore closed in phase 1.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

Event Description

Issue with screw head going through the plates and not engaging.

• Brand Name: CROSS PLATE LAPIDUS STEP, RT ANCHORAGE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7041006
• MDR Text Key: 93139507
• Report Number: 0008031020-2017-00661
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K083447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PLP29372S
• Device Lot Number: V07750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2017
• 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 Outcome(s): Other