MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, STST, LEFT GAMMA3® Ø11X320MM X 125°; IMPLANT

Catalog Number 43250320S

Device Problems Partial Blockage (1065); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 04/24/2017

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported by the pharmacist at the hospital that during a procedure, the nail remained blocked in the nail holder and it was impossible to retrieve it.So the medical staff had to remove the nail by force ( significant difficulty ) the surgery was delayed.The procedure completed well by using another nail.

Manufacturer Narrative

Evaluation revealed that the item did not contribute to the complained event, therefore it was classified as concomitant item.

Event Description

It was reported by the pharmacist at the hospital that during a procedure, the nail remained blocked in the nail holder and it was impossible to retrieve it.So the medical staff had to remove the nail by force ( significant difficulty ) the surgery was delayed.The procedure completed well by using another nail.

• Brand Name: LONG NAIL KIT R2.0, STST, LEFT GAMMA3® Ø11X320MM X 125°
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6697143
• MDR Text Key: 79737415
• Report Number: 0009610622-2017-00223
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 43250320S
• Device Lot Number: K474522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: No
• 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