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

Model Number	3525-0360S
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2020
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 discarded.
Event or Problem Description
As reported: "when i opened the long gamma 3 nail and tried to set it, i noticed that white debris had adhered to the nail.I took the one that adhered to the surface, but it might still be in the nail.A new nail was opened and used.The white debris was the scraped off spacer that fixed the nail.It was discarded.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device resp.Packaging reported was not returned to stryker and thus, a physical examination of the subject device was impossible.Review of the manufacturing documents revealed no discrepancies; the item was documented as faultless prior to distribution.More detailed information about the complaint event as well as the affected device and the packaging or its image in the original state must be available in order to determine the root cause of the complaint event.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "when i opened the long gamma 3 nail and tried to set it, i noticed that white debris had adhered to the nail.I took the one that adhered to the surface, but it might still be in the nail.A new nail was opened and used.The white debris was the scraped off spacer that fixed the nail.It was discarded.".

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT 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: 10218330
• Report Number: 0009610622-2020-00309
• Device Sequence Number: 2552382
• Product Code: HSB
• UDI-Device Identifier: 04546540375742
• UDI-Public: 04546540375742
• 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): 09/28/2020

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: 01/31/2025
• Device Model Number: 3525-0360S
• Device Catalogue Number: 35250360S
• Device Lot Number: K01EEA1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1