MAUDE Adverse Event Report: STRYKER GMBH HANSSON PIN TI 80MM; PIN, FIXATION, SMOOTH

Catalog Number 694080S

Device Problems Break (1069); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2014

Event Type  malfunction  

Event Description

During the inspection of the returned loner instruments from the hospital, it was found that the impactor broke.According to sales rep, the removed pin stuck to the inner introducer.

Manufacturer Narrative

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

Manufacturer Narrative

This investigation shall be performed by the legal manufacturer elos.All information received have been forwarded to elos for complaint investigations and regulatory reports.This record can be closed.

Event Description

During the inspection of the returned loner instruments from the hospital, it was found that the impactor broke.According to sales rep, the removed pin stuck to the inner introducer.

• Brand Name: HANSSON PIN TI 80MM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4120514
• MDR Text Key: 4922883
• Report Number: 0008031020-2014-00447
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/03/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2012
• Device Catalogue Number: 694080S
• Device Lot Number: T82799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/09/2015
• Initial Date FDA Received: 09/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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