MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X340MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 33250340S

Device Problems Break (1069); Fracture (1260)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994)

Event Date 04/09/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that patient stumbled on (b)(6) 2018 behind her walker and fell on her couch. She had sustained a "sub pertrochanteric fracture". An elongated gamma3 nail was placed in an (b)(6) female patient at (b)(6) 2018, position: left proximal femur. Post surgical protocol: mobilization in reliance on pain: patient used a walker for movement. After the initial surgery the patient could start carefully load her injured leg again following normal protocol. Patient didn¿t fall nor jump nor did anything else that compromised her health and recovery. In the first week of (b)(6) she developed pain in her left hip which persisted already a few days. On the (b)(6) an x-ray was taken. The nail seemed to be broken. That day or nurse, got in touch to investigate what instruments where available for extracting the broken nail and the revision or was planned on the (b)(6).

• Brand Name: LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X340MM X 125°
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 8597225
• MDR Text Key: 144668371
• Report Number: 0009610622-2019-00243
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 33250340S
• Device Lot Number: K05E004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2018
• 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: 05/09/2019 Patient Sequence Number: 1