MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DALL MILES. CRIMP BLOCK; IMPLANT

Catalog Number 0023-0-520

Device Problem Packaging Problem (3007)

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

Event Date 12/09/2014

Event Type  malfunction  

Event Description

It was reported that during the receiving process at stryker escs bv in venlo it was noticed that there is no product label pasted on the product packaging.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.The subject device is not cleared for sale in the u.S., but a similar device is commercially available in the u.S.

Manufacturer Narrative

Reported event: an event regarding a missing label involving a dall miles crimp block was reported.The event was confirmed.Method & results: -device evaluation and results: visual evaluation confirmed the label was missing from the pouch.-medical records received and evaluation: not performed because there was no patient involvement reported in this event as it occurred at incoming inspection at a distribution center.-device history review: a device history review indicated that all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: a complaint history review indicated that there have been no similar events for the reported lot.Conclusions: the investigation concluded that the missing label on a package was supplier related.A capa investigation has been opened.

Event Description

It was reported that during the receiving process at stryker (b)(4) it was noticed that there is no product label pasted on the product packaging.

• Brand Name: DALL MILES. CRIMP BLOCK
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4370528
• MDR Text Key: 5236829
• Report Number: 0002249697-2014-05018
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 0023-0-520
• Device Lot Number: G5576645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2014
• 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