MAUDE Adverse Event Report: STRYKER TRAUMA KIEL END CAP T2 PROX. HUM. Ø10 MM, +4 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 18320004S

Device Problems Device Expiration Issue (1216); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2018

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 reported by the pharmacist from the clinic, to the sales rep, that "the end cap was implanted but was expired since (b)(6) 2017.The device was part of a consignment kit, and the nurse did not verify the expiry date before implantation.".

Event Description

It was reported by the pharmacist from the clinic, to the sales rep, that "the end cap was implanted but was expired since sept 30th, 2017.The device was part of a consignment kit, and the nurse did not verify the expiry date before implantation.".

Manufacturer Narrative

The reported event that end cap t2 prox.Hum.Ø10 mm, +4 mm was alleged of issue k-345 (sterile period expired) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Previous complaints are known regarding expired sterility.The evaluations revealed that real aging tests were performed with stryker implants in 2007 reveal that there is a safety tolerance; implants with exceeded expiry date were checked more than 1 year overdue and considered still sterile subsequently.The expiry date is a theoretical date which offers a high level of safety and the risk of an infection caused by a simple transgression of the expiry date is negligible.A consultant hcp stated in a similar case that a risk for the patient is not to be expected although an expired nail (exceeded by approx.6 months) had been implanted.A review of the labeling did not indicate any abnormalities.Thus, based on the investigation the root cause could be assigned to a user related issue.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: END CAP T2 PROX. HUM. Ø10 MM, +4 MM
• 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: 7383213
• MDR Text Key: 104138772
• Report Number: 0009610622-2018-00084
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K032523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 18320004S
• Device Lot Number: K684716
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other