MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA 3 NAIL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNK_KIE

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Ambulation Difficulties (2544); Implant Pain (4561)

Event Date 12/17/2014

Event Type  Injury  

Event Description

The manufacturer became aware of a literature published by the ¿orthopaedic department, parc de salut mar, spain¿.The title of this report is ¿salvage for nail breakage in femoral intramedullary nailing¿, published on december 17, 2014, and can be found at http://dx.Doi.Org/10.1016/j.Injury.2014.12.003.The report is associated with the stryker ¿gamma 3 nailing system¿ and includes an analysis of the clinical data that was collected on 1246 patients.The cases in this study range from january 2003 to december 2012.During the review of the literature, it was not possible to establish a precise device(s) identification or patient information; however, the article alleges that one (1) patient experienced implant rupture in the proximal nail aperture, which required revision with a dynamic condilar screw.The report states, ¿all these patients presented hip pain, lameness, and serious difficulty in walking during the postoperative period until the diagnosis of implant breakage was made.All of them lacked a consolidation of the fracture focus at 6 months follow-up¿.

Manufacturer Narrative

This complaint has been generated based on findings identified during post market surveillance literature review published by the ¿orthopaedic department, parc de salut mar, spain¿.The article can be found at http://dx.Doi.Org/10.1016/j.Injury.2014.12.003.The reported event of implant rupture, which required revision, could not be confirmed since the device was not returned for evaluation and no other additional information was received from the author.  more detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause.   if any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

• Brand Name: UNKNOWN GAMMA 3 NAIL
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15262573
• MDR Text Key: 298279001
• Report Number: 0009610622-2022-00391
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Date Manufacturer Received: 07/26/2022
• 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): Required Intervention
• Patient Age: 82 YR