MAUDE Adverse Event Report: STRYKER GMBH SUPERELASTIC IMPLANT X FUSE STANDARD / ANGLE 15°; PIN, FIXATION, SMOOTH

Catalog Number AXFS15

Device Problems Component Missing (2306); Packaging Problem (3007)

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

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Sales rep, reported that the following event : "i was in the operating room today and one of 2 delivered implants boxes was empty.Blister was removed, there was only a label inside, without the implant.No impact on the procedure as there were two other implants available.".

Manufacturer Narrative

The reported incident that superelastic implant x fuse standard / angle 15° was alleged of issue s-139 (device missing) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Based on investigation, the root cause was attributed to a user related issue as the returned box was opened, without any blister, with a label and an empty opened pouch in it.It was reported that "one of 2 delivered implants boxes was empty.Blister was removed, there was only a label inside, without the implant¿.Therefore it is not possible to confirm the failure mode.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

Event Description

Sales rep, reported that the following event : "i was in the operating room today and one of 2 delivered implants boxes was empty.Blister was removed, there was only a label inside, without the implant.No impact on the procedure as there were two other implants available.".

• Brand Name: SUPERELASTIC IMPLANT X FUSE STANDARD / ANGLE 15°
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 5300182
• MDR Text Key: 34122846
• Report Number: 0008031020-2015-00496
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AXFS15
• Device Lot Number: 151210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/20/2015
• 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