MAUDE Adverse Event Report: STRYKER TRAUMA KIEL K-WIRE GAMMA Ø3,2X450 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 12106450S

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Inthe in-coming inspection at distribution, it was found that there was a foreign material (particle and hair) in blister.

Manufacturer Narrative

The reported event that k-wire gamma 3,2x450 mm was alleged of issue (packaging: hair outside sterile blister or pouch) could be confirmed, since the device was returned and matches alleged failure mode.During the visual inspection of the item received a foreign particle 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 ¿in-coming inspection at distribution¿.A review of the dhr revealed no discrepancies.Sealing seams and original packaging are still intact.If any further information is provided, the investigation report will be reassessed.

Event Description

In in-coming inspection at distribution, it was found that there was a foreign material (particle and hair) in blister.

• Brand Name: K-WIRE GAMMA Ø3,2X450 MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7205936
• MDR Text Key: 97904384
• Report Number: 0009610622-2018-00020
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 12106450S
• Device Lot Number: K06385E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other