MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH DALL MILES VIT 2.0MM CABLE; CERCLAGE, FIXATION

Catalog Number 6704-8-240

Device Problems Component Missing (2306); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2016

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Although it was a revision, it was a revision of a wright medical total hip.The reason for the product experience report is because, when the hospital opened the box with the 2.0 cable in it, there was no crimper with the cable.The hospital used the cable because they had a crimper available.

Manufacturer Narrative

An inquiry regarding a packaging issue involving an dall miles vit 2.0mm cable was reported.The event was not confirmed.There is no indication that the product reported in this investigation was nonconforming.A review of drawing number (b)(4) af rev a - dall miles vitallum cable blister packaging assembly, showed that there is no crimper packed with this product no further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Although it was a revision, it was a revision of a wright medical total hip.The reason for the product experience report is because, when the hospital opened the box with the 2.0 cable in it, there was no crimper with the cable.The hospital used the cable because they had a crimper available.

• Brand Name: DALL MILES VIT 2.0MM CABLE
• Type of Device: CERCLAGE, FIXATION
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5822363
• MDR Text Key: 51124065
• Report Number: 0002249697-2016-02426
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2016

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: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 6704-8-240
• Device Lot Number: 53971002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2016
• Initial Date FDA Received: 07/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2015
• 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
• Patient Age: 56 YR