MAUDE Adverse Event Report: STRYKER GMBH 5 HOLE PIN CLAMP HOFFMANN 3 Ø4/5/6MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 49222020

Device Problem Fitting Problem (2183)

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

Event Date 01/14/2016

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

When dr.Assembled a kit, 5 holes pin crump single fix ( curved 30 degree 11mm diameter of rod) , a post couldn't insert to the hole.Dr.Inserted the rod by using hammer.However, other crump couldn't insert a rod.So, dr.Assembled a frame by pin connector.

• Brand Name: 5 HOLE PIN CLAMP HOFFMANN 3 Ø4/5/6MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 5493913
• MDR Text Key: 40328081
• Report Number: 0008031020-2016-00119
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• PMA/PMN Number: K121252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 49222020
• Device Lot Number: J41545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2016
• Initial Date FDA Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2015
• 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