MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø13X400MM X 125° IMPLANT

Catalog Number 32253400S

Device Problems Break (1069); Crack (1135)

Patient Problem Pain (1994)

Event Date 06/18/2018

Event Type  Injury  

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 that the first surgery for pertr. Was performed with a long gamma nail on (b)(6) 2017. Patient came in with pain and non-union. Removal of the nail - mibi samples were collected for the exclusion of infection (there was no infection found). Reosteosynthesis on (b)(6) 2017 with pseudarthrosis removal, allogenic spongiosaplasty, open reduction and cable cerclage and special nail t2: 13 mm diameter, 400 mm in length, 125 ccd. Initial clinical and x-ray controls showed auto dynamization (bolt break distal) and incipient healing, patient fully loaded symptom free, felt cracking on (b)(6)- x-ray-diagnostic - nail breakage. Plan now: revision planned. Date of revision is unknown.

• Brand Name: LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø13X400MM 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: 7648500
• MDR Text Key: 112702114
• Report Number: 0009610622-2018-00248
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 32253400S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/28/2018 Patient Sequence Number: 1