MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, STST GAMMA3® Ø10.5X90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 40600090S

Device Problems Metal Shedding Debris (1804); Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problems Radiation Exposure, Unintended (3164); Device Embedded In Tissue or Plaque (3165)

Event Date 08/21/2017

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 hospital that, during surgery, the surgeon failed to introduce the lag screw into the gamma nail.After many attempts, the surgeon asked for another lag screws but the same problem remained (with screws reference : 40600090s lot k0c9597 / k0a0c0c and k0286d5).As a consequence, the surgeon used a different distal targeting device.This new attempt was unsuccessful.The surgeon decided to retrieve the gamma nail and replaced it by a new one and resulted in a successful attempt with the nail 41250080s lot ku74188 and the lag screw ref 40600085s lot k064a7d." adverse consequences, surgical delay = 1hour and 50 minutes instead of 30 minutes - increases the level of irradiation inflicted on the patient.It is possible that metal particles have been released in the patient at the time of the screwing attempt.

Manufacturer Narrative

The evaluation revealed the nail and lag screws to be the primary products.No deviations were found during review of the manufacturing and inspection documents (dhr).The products returned were documented as faultless prior to distribution.During investigation no material, dimensional, functional, visual or manufacturing related issues were found.The reported event was confirmed; the diameter of the proximal lag screw nail hole got slightly decreased by abraded nail material that was embedded within the nail hole.The material got abraded by the lag screw step drill; both bridges of the nail were found drill damaged at lateral.Due to this drill damage a lag screw insertion was not possible during surgery.All lag screws showed partly abraded surfaces due to contact with the embedded material within the nail hole.Additionally, it was found that the nail was also drill damaged at the lower groove edge and lower nail hole at lateral, caused by drilling in a wrong ccd angle (130¿ instead of 125¿).The functional check revealed that all lag screws were insertable through the nail hole, although the nail and lag screws were damaged.Furthermore, a sample stepdrill passed the proximal nail hole without nail contact.The drill damages are caused by mis-drilling.Mis-drilling of the proximal hole can have several potential causes: damaged instruments, bending forces applied to the lag screw step drill during drilling, unlocked targeting sleeve, drilling without drill sleeve, deflected k-wire, nail holding screw was not tightened.All these potential causes are addressed in the ifu and operative technique.Because no manufacturer related issue was detected the case is attributed to a deviation of the ifu and operative technique (user related).Review of complaint history, capa databases, labelling and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.

Event Description

It was reported by the hospital that, during surgery, the surgeon failed to introduce the lag screw into the gamma nail.After many attempts, the surgeon asked for another lag screws but the same problem remained (with screws reference : 40600090s lot k0c9597 / k0a0c0c and k0286d5).As a consequence, the surgeon used a different distal targeting device.This new attempt was unsuccessful.The surgeon decided to retrieve the gamma nail and replaced it by a new one and resulted in a successful attempt with the nail 41250080s lot ku74188 and the lag screw ref 40600085s lot k064a7d." adverse consequences, surgical delay = 1hour and 50 minutes instead of 30 minutes - increases the level of irradiation inflicted on the patient.It is possible that metal particles have been released in the patient at the time of the screwing attempt.

• Brand Name: LAG SCREW, STST GAMMA3® Ø10.5X90MM
• 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: 6874853
• MDR Text Key: 87342268
• Report Number: 0009610622-2017-00289
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K043431
• 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: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 40600090S
• Device Lot Number: K0A0C0C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2017
• 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