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
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7069103
• Report Number: 0009610622-2017-00359
• Device Sequence Number: 13732998
• Product Code: HSB
• UDI-Device Identifier: 04546540375308
• UDI-Public: 04546540375308
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 34250260S
• Device Lot Number: K0E5991
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention