MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R2.0, TI, RIGHT T2 RECON Ø9X420 MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18470942S

Device Problem Use of Device Problem (1670)

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

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device evaluated by mfr: device remains implanted.

Event Description

Customer reported to the rep through the phone that an expired trauma implant was implanted.No adverse consequences were reported.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Based on the event description (re-ordering the item for replenishment, it was realized the implant had expired), the root cause was attributed to user related issue.As mentioned in the ifu, ¿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 nonsterile.¿ the device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that, ¿for detailed information concerning the identification of the product (such as system association, catalog no.(ref), material, expiration date of sterile products) please refer to the marking on the product and/or the labeling of the package¿ if device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

Customer reported to the rep through the phone that an expired trauma implant was implanted.The implant was taken into surgery and was successfully implanted.After the case when re-ordering the item for replenishment, it was realized the implant had expired.No adverse consequences or surgical delay were reported.

Manufacturer Narrative

Sections were corrected with the specific device information.510(k) number was added.

Event Description

Customer reported to the rep through the phone that an expired trauma implant was implanted.The implant was taken into surgery and was successfully implanted.After the case when re-ordering the item for replenishment, it was realized the implant had expired.No adverse consequences or surgical delay were reported.

• Brand Name: RECONSTRUCTION NAIL R2.0, TI, RIGHT T2 RECON Ø9X420 MM X 125°
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8537093
• MDR Text Key: 143978414
• Report Number: 0009610622-2019-00212
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K032898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 18470942S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1