MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN APEX HALF PIN; IMPLANT

Catalog Number UNK_SEL

Device Problems Shelf Life Exceeded (1567); Improper or Incorrect Procedure or Method (2017)

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

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.It was left in the patient body.

Event Description

The doctor deployed the apex pin for the patient whose sterization deadline in (b)(6) 2018 on (b)(6) 2018.A product whose sterilization period has expired was placed in a patient.

Event Description

The doctor deployed the apex pin for the patient whose sterization deadline in (b)(6) 2018 on (b)(6) 2018.A product whose sterilization period has expired was placed in a patient.

Manufacturer Narrative

The reported event that unknown_selzach_product was alleged of 'known misuse reported by the user' (device implanted after end of sterilization date) 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.The failure was caused by mismanagement of the shelf life of the device.It remains hospital responsibility to check that all available material is conformed before the surgery.The instruction for use (v15013 rev aa non active implant ifu ot-ifu-105 rev 4) reads: ''the packaging of all sterile products should be inspected for flaws in the sterile barrier or expiration of shelf life before opening.In the presence of such a flaw or expiration of shelf life, the product must be assumed non-sterile.Care must be taken to prevent contamination of the component.In the event of contamination, or expiration of shelf life or in the case of products supplied non-sterile, the product must be subjected to an appropriate cleaning process and sterilized by means of a validated sterilization procedure before use, unless specified otherwise in the product labeling or respective product technical guides.Products which have already been used in a surgically invasive manner, even if implanted only partly or temporarily during the surgical procedure, must not be reprocessed for reuse.¿ [original statement].Therefore this case is classified as user related.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.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.

• Brand Name: UNKNOWN APEX HALF PIN
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7473648
• MDR Text Key: 107218917
• Report Number: 0008031020-2018-00331
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2018

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: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2018
• Initial Date FDA Received: 04/30/2018
• Supplement Dates Manufacturer Received: 05/31/2018
• Supplement Dates FDA Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other