MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL INSERTION SLEEVE, ELASTIC T2 TIBIA SPI 8-11; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1806-1406S
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that during surgery the physician found a different device from packaging label at opening of the packaging.There was 18061407s, ø8mm-13mm in the 18061406s, ø8mm-11mm packaging.
Event or Problem Description
It was reported that during surgery the physician found a different device from packaging label at opening of the packaging.There was 18061407s, ø8mm-13mm in the 18061406s, ø8mm-11mm packaging.
Additional Manufacturer Narrative
The reported event could be confirmed, based on verification of received parts and due to the fact that a similar reported case, which was vice versa, was confirmed by stock check.However, identification in original condition of the item in question was impossible as the device in question was already out of its primary packaging.Based on investigation, it could not be excluded that the root cause was attributed to a manufacturing related issue and thus, it has to be classified as a mix-up.The device inspection revealed the following: visual inspection: we received a secondary packaging of a nail insertion sleeve, elastic t2 tibia spi ø8-11 of lot code k03cc4f with ripped overwrapping.After unpacking the cardboard box an already unpacked nail insertion sleeve, elastic t2 tibia spi ø8-13 of unknown lot code becomes visible out of its corresponding primary packaging [clear tubular bag].Detailed inspection of the sleeve bottom revealed following identifiers for a nail insertion sleeve, elastic t2 tibia spi ø8-13 as specified per current drawing: 8-13.Catalogue #1806-1407.Dateclock with manufacturer year and month.Dateclock with coundnumber 0-9.Ce mark with notified body number.Functional inspection: due to the nature of the complaint, a functional inspection was not considered necessary.Dimensional inspection: due to the nature of the complaint, a dimensional inspection was not considered necessary.A review of the device history for the reported lot did not indicate any abnormalities.The case is addressed according to our internal procedures and further root cause investigation will be performed under already triggered process.

• Brand Name: NAIL INSERTION SLEEVE, ELASTIC T2 TIBIA SPI 8-11
• 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: 11345796
• Report Number: 0009610622-2021-00284
• Device Sequence Number: 3347504
• Product Code: HSB
• UDI-Device Identifier: 04546540715357
• UDI-Public: 04546540715357
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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: 07/31/2025
• Device Model Number: 1806-1406S
• Device Catalogue Number: 18061406S
• Device Lot Number: K03CC4F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1