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

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 11/19/2019

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 191619278
• Report Number: 0009610622-2019-00981
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 04546540195890
• UDI-Public: 04546540195890
• Combination Product (y/n): N
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1