MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN 7 FRENCH DRAIN SYSTEM STERILE; INSTRUMENT

Catalog Number 6640

Device Problems Break (1069); Fracture (1260)

Patient Problem Unspecified Infection (1930)

Event Date 07/25/2014

Event Type  Injury  

Event Description

The product was placed / used for a first stage ear construction on (b)(6) 2014.It was stated that the fracture of the tubes occured 5 to 7-days after placement the event date was for this case approximately (b)(6) 2014.It was also stated that the drains broke at the place where they insert into the metal phalange.In both cases, because the systems were open to air/environment infection developed, and the patients required iv antibiotics for 4 to 6 days.

Manufacturer Narrative

Device not returned for evaluation as it was discarded by the hospital.If additional information is received it will be reported on a supplemental report.Device discarded.

• Brand Name: 7 FRENCH DRAIN SYSTEM STERILE
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer (Section G): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer Contact: jamshed badarpura ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 4064946
• MDR Text Key: 18873489
• Report Number: 0008010177-2014-00243
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K800581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6640
• Device Lot Number: M1404001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2014
• Initial Date FDA Received: 09/05/2014
• 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