MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR 2.3 W 1UB II BLUE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number ED72201991

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 10/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the distal end of the anchor broke off upon insertion.A backup device was readily available to complete the procedure with a short delay.No patient injury was reported.

Manufacturer Narrative

Due no product return, the complaint could not be confirmed.Definitive conclusions cannot be made without a device to evaluate.Accurate investigation and evaluation are not possible.The product met specifications upon release to distribution.

• Brand Name: OSTEORAPTOR 2.3 W 1UB II BLUE
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: james gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7051312
• MDR Text Key: 92775853
• Report Number: 1219602-2017-01453
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 03596010615527
• UDI-Public: (01)03596010615527(17)220731(10)50677304
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

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: 07/31/2022
• Device Model Number: ED72201991
• Device Catalogue Number: ED72201991
• Device Lot Number: 50677304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 11/28/2017
• Supplement Dates FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2017
• 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