MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN HUMERAL NAIL LONG; IMPLANT

Catalog Number UNK_KIE

Device Problem Difficult to Remove (1528)

Patient Problem Pain (1994)

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device remains implanted.

Event Description

It was reported the hospital, reported to the (b)(6) the following event: "impossibility of removal of osteosynthesis material by matting of the extraction screw thread.The patient keeps her humeral nail for life, with septic risk and chronic pain at temperature changes.Multiple trials of ablation without success.I think the use titanium for medullary nails is a taboo and should be banned.The patient keeps her humeral nail for life, with septic risk and chronic pain at temperature changes.

• Brand Name: UNKNOWN HUMERAL NAIL LONG
• 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: 7713327
• MDR Text Key: 114956615
• Report Number: 0009610622-2018-00385
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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