MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG 2.3X26MM LOCKING SCREWS,CROSS-PIN,SELF-T; PLATE, FIXATION, BONE

Catalog Number 53-23026

Device Problem Device Expiration Issue (1216)

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

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was confirmed the issue on (b)(6) 2017.There was used 4screws out of sterilization on (b)(6) 2016.The product was expired already.

Manufacturer Narrative

The reported event that 2.3x26mm locking screws, cross-pin, self-t was alleged of 'known misuse reported by the user' 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 be user related: this is the operative room staff responsibility to check sterility and integrity of the device before implanting it.In addition, devices were sent to customer when they were out of date of usage; sterility was not ensure.The distribution site has been contacted and a nc will be opened to address this situation and to avoid any new occurrence in the future.However, it remains hospital responsibility to check that all available material is conformed before the surgery.The instruction for use (v15013 rev n non active implant ifu) reads: ''for detailed information concerning the identification of the product (such as system association, catalogue no.(ref), material, expiration date of sterile products) please refer to the marking on the product and/or the labeling of the package.¿ [original statement] therefore this case is classified as user related.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was confirmed the issue on (b)(6) 2017.There was used 4 screws out of sterilization on (b)(6) 2016.The product was expired already.

• Brand Name: 2.3X26MM LOCKING SCREWS,CROSS-PIN,SELF-T
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6376868
• MDR Text Key: 69344203
• Report Number: 0008010177-2017-00041
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K062498
• 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,Followup
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 53-23026
• Device Lot Number: 1000004939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2011
• 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