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

Model Number	72201991
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the distal end of the anchor broke off upon insertion.A backup device was readily available and no patient injury was reported.
Additional Manufacturer Narrative
Examination was not possible, as the device will not be returned.The investigation could not draw any conclusions about the reported event without the return of the device.A review of the ncmr database was performed which confirmed no abnormalities were reported with this lot during manufacture.A complaint history review identified one additional complaint for this manufactured lot.

• Brand Name: OSTEORAPTOR 2.3 W 1UB II BLUE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 6976803
• Report Number: 1219602-2017-01333
• Device Sequence Number: 648896
• Product Code: MAI
• UDI-Device Identifier: 03596010615527
• UDI-Public: (01)03596010615527(17)220731(10)50677304
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 72201991
• Device Catalogue Number: 72201991
• Device Lot Number: 50677304
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1