MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X360MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-0360S
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device was implanted.Only packaging is available.
Event or Problem Description
As reported: "the physician found plastic powder on the device, when the packaging was opened." additionally reported: "the physician cleaned powder on the device and used it." "the sponge [foam of the packaging] was worn.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the implant in question was not returned for evaluation and no other evidence was provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The pollution could have been best presented in original condition, which would have been possible in this case.It could not be excluded that the alleged pollution occurred during unpacking the device at user site, which is supported by the evident signs of damage verified at the foam protector.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.
Event or Problem Description
As reported: "the physician found plastic powder on the device, when the packaging was opened." additionally reported: - "the physician cleaned powder on the device and used it." - "the sponge [foam of the packaging] was worn".

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X360MM 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; GM D-24232
• MDR Report Key: 10370513
• Report Number: 0009610622-2020-00438
• Device Sequence Number: 3004841
• Product Code: HSB
• UDI-Device Identifier: 04546540375353
• UDI-Public: 04546540375353
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 3425-0360S
• Device Catalogue Number: 34250360S
• Device Lot Number: K075B9F
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1