MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN_SELZACH_PRODUCT; IMPLANT

Catalog Number UNK_SEL

Device Problem Mechanics Altered (2984)

Patient Problem No Patient Involvement (2645)

Event Date 06/17/2015

Event Type  malfunction  

Event Description

During variax clavicle surgery, the surgeon bent the plate to adjust it to the shape of the bone.When the surgeon inserted the locking screw in screw hole of the plate, the locking screw didn't lock.Therefore the locking screw was inserted in different screw hole, but the locking screw didn't lock.The surgeon changed the plate to another plate.

Manufacturer Narrative

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

Manufacturer Narrative

The reported incident could not be confirmed, since the device was not returned for evaluation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

During variax clavicle surgery, the surgeon bent the plate to adjust it to the shape of the bone.When the surgeon inserted the locking screw in screw hole of the plate, the locking screw didn't lock.Therefore the locking screw was inserted in different screw hole, but the locking screw didn't lock.The surgeon changed the plate to another plate.

• Brand Name: UNKNOWN_SELZACH_PRODUCT
• Type of Device: IMPLANT
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4910527
• MDR Text Key: 16561067
• Report Number: 0008031020-2015-00292
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 06/17/2015

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: Health Professional
• Device Catalogue Number: UNK_SEL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 07/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/10/2015
• 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