MAUDE Adverse Event Report: STRYKER GMBH (MDR) UNKNOWN_SELZACH_PRODUCT; IMPLANT

Catalog Number UNK_SEL

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/27/2015

Event Type  malfunction  

Manufacturer Narrative

Catalog number is unknown at this time.The device was reported as an unknown variax dist radius screw.If additional information becomes available it will be provided on a supplemental report.Product disposition is unknown.

Event Description

It was reported that after the screw was tightened in the plate, the head of the screw came off.The head was retrieved and the screw was left in the patient.This was a left wrist surgery.

• Brand Name: UNKNOWN_SELZACH_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH (MDR); bohnackerweg 1; postfach; selzach 02545 ; CH 02545
• Manufacturer (Section G): STRYKER GMBH (MDR); bohnackerweg 1; postfach; selzach 02545 ; CH 02545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5085077
• MDR Text Key: 26428631
• Report Number: 0008031020-2015-00384
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Report Date: 08/27/2015

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: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• 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