MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNIVERSAL IMPACTOR STAPLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 69831000

Device Problems Break (1069); Component Falling (1105)

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

Event Date 02/26/2014

Event Type  malfunction  

Event Description

It was reported that while the surgeon was impacting the stamp, the product broke.The broken piece dropped to the floor.The procedure was delayed less then 10 minutes.It was reported that the product had been in service for 3-5 months.

Manufacturer Narrative

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

Manufacturer Narrative

The device is regarded to be a concomitant product ¿ it did not contribute to the event.

Event Description

It was reported that while the surgeon was impacting the stamp, the product broke.The broken piece dropped to the floor.The procedure was delayed less then 10 minutes.It was reported that the product had been in service for 3-5 months.

• Brand Name: UNIVERSAL IMPACTOR STAPLE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-24 232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-24 232
• Manufacturer Contact: rose mincieli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3684557
• MDR Text Key: 4255294
• Report Number: 0009610622-2014-00126
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 02/28/2014

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 Catalogue Number: 69831000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/24/2014
• Initial Date FDA Received: 03/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other