MAUDE Adverse Event Report: STRYKER TRAUMA SELZACH UNKNOWN_OSTEOSYNTHESIS_PRODUCT; IMPLANT

Catalog Number UNK_OST

Device Problem Fitting Problem (2183)

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

Event Date 08/27/2014

Event Type  malfunction  

Event Description

The customer reported via the sales representative that the 14mm variax elbow screw allegedly did not lock onto the plate.

Manufacturer Narrative

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

• Brand Name: UNKNOWN_OSTEOSYNTHESIS_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER TRAUMA SELZACH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4100452
• MDR Text Key: 4714139
• Report Number: 0008031020-2014-00434
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2014

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: UNK_OST
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2014
• Initial Date FDA Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: No
• 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