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

Catalog Number UNK_SEL

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/11/2015

Event Type  malfunction  

Event Description

During locking the anchorage lisfranc plate (proximal), lock screw plsl3022 went all the way through the hole.Surgeon changed the locking screw to plsl3522 and that item worked fine.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event that anchorage plate had a screw through the plate during surgery could not be confirmed, since the device was not returned for evaluation.The root cause of this positioning issue has been identified as a design issue.This problem has been identified during (b)(4) and is addressed by (b)(4).A new design will be implemented as soon as validated.

Event Description

During locking the anchorage lisfranc plate (proximal) lock srew plsl3022 went all the way through the hole.Surgeon changed the locking screw to plsl3522 and that item worked fine.

• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4903575
• MDR Text Key: 19350200
• Report Number: 0008031020-2015-00286
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SEL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/29/2015
• 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