MAUDE Adverse Event Report: STRYKER TRAUMA KIEL GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA Ø3X800 MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	1806-0080S
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/19/2019
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
It was reported, during an in-coming inspection at distribution, it was found that there was a foreign material (hair) in blister package.This event was found on 1 of 90 units with lot# k0ac0b4.
Event or Problem Description
It was reported, during an in-coming inspection at distribution, it was found that there was a foreign material (hair) in blister package.This event was found on (b)(4) units with lot#k0ac0b4.
Additional Manufacturer Narrative
The reported event could be confirmed.During the visual inspection of the item received a hair was found out of the sterile barrier between the clear tube and the pouch within the secondary packaging.According to details received it was detected during ¿in-coming inspection¿.A review of the dhr revealed no discrepancies.Sealing seams and original packaging are still intact.Thus, it has been determined the pollution must have occurred during the packaging process, which was not detected during inspection.Based on the above facts the root cause of the reported event is related to an inadequate packaging process / insufficient inspection specification.

• Brand Name: GUIDE WIRE, BALL-TIPPED, STERILE T2 TIBIA Ø3X800 MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; DE D-24232
• MDR Report Key: 9513692
• Report Number: 0009610622-2019-00981
• Device Sequence Number: 2703036
• Product Code: LPH
• UDI-Device Identifier: 04546540195890
• UDI-Public: 04546540195890
• Combination Product (Y/N): N
• PMA/510(K) Number: K153345
• 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): 03/23/2020

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: Other
• Device Expiration Date: 09/30/2024
• Device Model Number: 1806-0080S
• Device Catalogue Number: 18060080S
• Device Lot Number: K0AC0B4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1