MAUDE Adverse Event Report: STRYKER TRAUMA KIEL GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060085S
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
In in-coming inspection at distribution, it was found that there was a foreign material (hair / bug) in blister.This event was found on 1 of 50pcs of 18060080s, lot# k0b324f received on our (b)(4)and 1 of 100pcs of 18060085s, lot# k09a2f3 received on our (b)(4).No patient involvement, adverse consequences, delay or medical intervention.
Event or Problem Description
In in-coming inspection at distribution, it was found that there was a foreign material (hair / bug) in blister.This event was found on 1 of 50pcs of 18060080s, lot# k0b324f.Received on our po#60075092 and 1 of 100pcs of 18060085s, lot# k09a2f3 received on our po#60076929.No patient involvement, adverse consequences, delay or medical intervention.
Additional Manufacturer Narrative
The reported event that guide wire, ball-tipped, sterile t2 femur ø3x1000 mm [packaging] was alleged of - packaging: insect outside sterile blister or pouch could be confirmed.Based on investigation, the root cause was attributed to a supplier related issue.The failure was caused by an inadequate packaging process / insufficient inspection specification.The device inspection revealed the following: during the visual inspection of the item received an insect was found between the clear tube and the pouch.Sealing seams and original packaging are still intact.Thus, the pollution must have occurred during the packaging process at our sub-supplier, which was not detected during inspection.A review of the device history for the reported lot did not indicate any abnormalities.

• Brand Name: GUIDE WIRE, BALL-TIPPED, STERILE T2 FEMUR Ø3X1000 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8121785
• Report Number: 0009610622-2018-01495
• Device Sequence Number: 16557421
• Product Code: LXH
• UDI-Device Identifier: 04546540195937
• UDI-Public: 04546540195937
• Combination Product (Y/N): N
• 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): 12/27/2018

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: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 18060085S
• Device Lot Number: K09A2F3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 12/01/2018
• Supplement Report FDA Received Date: 12/27/2018
• 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: Other