MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X420MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 32250420S

Device Problems Break (1069); Patient-Device Incompatibility (2682)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/30/2016

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 gamma3 long nail has broken (during an accident).The implant has been provided with the product manager in (b)(6).The surgeon reported that the collim screw was too short.

Manufacturer Narrative

The evaluation revealed the broken gamma3 long nail and the lag screw to be the primary products.No deviations were found during review of the manufacturing and inspection documents (dhr).The nail and lag screw returned were documented as faultless prior to distribution.During investigation no material, dimensional or manufacturing related issues were found.Regarding nail: the breakage surfaces and breakage lines indicate that the nail breakage started at lateral at the anterior bridge.The anterior bridge broke approx.To its half in a fatigue fracture (step by step).The rest of the anterior bridge and the complete posterior bridge broke spontaneous in a forced gliding fracture due to one single heavy overload.No drill marks were visible within the proximal nail hole.Deep bearing points from the lag screw indicate that several postoperative loads were applied to the implants; most likely the patient walked actively prior to the accident.Based on the given information the nail broke due to the accident by the patient (patient related).Postoperative loads and additional traumata can lead to implant breakages and are listed as adverse effects in the ifu and operative technique.Review of complaint history, capa databases 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 that gamma3 long nail has broken (during an accident).The implant has been provided with the product manager in (b)(6).The surgeon reported that the collim screw was too short.

• Brand Name: LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X420MM 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: 6271346
• MDR Text Key: 65539943
• Report Number: 0009610622-2017-00037
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: 32250420S
• Device Lot Number: K0CC55E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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: 89 YR
• Patient Weight: 85