MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE; STAPLE, FIXATION, BONE

Model Number 72201994

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/13/2015

Event Type  malfunction  

Event Description

During a bankart repair using the osteoraptor 2.9 w/ 1 ub cobraid blue, it was reported that the osteoraptor on two occasions pulled out when the knots were tied.They tried a third osteoraptor from a different lot number and this was successful.The patient was reported to have normal bone quality.The site was reported to have been prepared per instructions; by placing the drill guide, drill and then tap anchor into place.An osteoraptor specific drill was used.The device did not break, it just pulled out.They needed to prepare another site to complete the procedure; the original site was left empty.There was a delay of 15 minutes.The patient was noted to be okay post-procedure.

Manufacturer Narrative

The device was marked as available for evaluation; although anticipated, the device has not yet been received.(b)(4).

Manufacturer Narrative

Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: meaghan atwell ; 150 minuteman road; andover, MA 01810 ; 9787491317
• MDR Report Key: 4690347
• MDR Text Key: 5711893
• Report Number: 1219602-2015-00069
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: K082215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 03/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2019
• Device Model Number: 72201994
• Device Catalogue Number: 72201994
• Device Lot Number: 50531839
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2015
• Date Device Manufactured: 12/19/2014
• 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