MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X260MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 34250260S

Device Problems Fracture (1260); Improper or Incorrect Procedure or Method (2017)

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

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device disposition is unknown.

Event Description

The physician accidentally deployed the right long gamma nail on the left.Although it fixed as it was, recurrent fracture was confirmed at after operation xp and the nail was replaced.

Manufacturer Narrative

Product inquiry states the long nail kit r1.5, ti, right gamma3® ø10x260mm x 125° to be the primary product.No further associated products were reported.Review of the device history records, in particular the labelling copy sheet, revealed no discrepancies.A physical examination could not be carried out as the device was not returned to stryker (b)(4).As no further information such as x-ray images were provided due to hospital policy.The reported event could therefore not be confirmed.The event description states that ¿the physician accidentally deployed the right long gamma nail on the left¿.However, the labels on the packaging clearly indicate left and right nail by capital letters.The written description is available on the outer box as well as on the blister inside.In addition, left or right is engraved on the gamma3 long nail accordingly.Based on the above facts the root cause of the reported event is not linked to a deficiency of the device but is rather related to deviation from surgical technique by the user.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no open actions in place related to the reported event for the subject product.No non-conformity was identified.

Event Description

The physician accidentally deployed the right long gamma nail on the left.Although it fixed as it was, recurrent fracture was confirmed at after operation xp and the nail was replaced.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X260MM 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7069103
• MDR Text Key: 93286592
• Report Number: 0009610622-2017-00359
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540375308
• UDI-Public: 04546540375308
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 34250260S
• Device Lot Number: K0E5991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention