MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR 2.9 W 1UB II BLUE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72202165
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while tying the knot, the anchor came out of the glenoid.A backup device was available to complete the procedure with no significant delay or patient injuries.
Additional Manufacturer Narrative
Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.
Event or Problem Description
It was reported that while tying the knot, the anchor came out of the glenoid.Anchor broke, all pieces were removed from the patient.Another bone hole was required.A backup device was available to complete the procedure with no significant delay or patient injuries.
Additional Manufacturer Narrative
One 2.9 osteoraptor inserter was returned for evaluation.No anchor or sutures were returned for examination prohibiting confirmation of the reported complaint of anchor breakage.Visual assessment of the inserter showed no damage.Dimensional assessment of the inserter found it met print specifications.

• Brand Name: OSTEORAPTOR 2.9 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: 7503113
• Report Number: 1219602-2018-00551
• Device Sequence Number: 16531705
• Product Code: MAI
• UDI-Device Identifier: 03596010615589
• UDI-Public: (01)03596010615589(17)200105(10)50532062
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K151105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/20/2018

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: 01/05/2020
• Device Model Number: 72202165
• Device Catalogue Number: 72202165
• Device Lot Number: 50532062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 04/15/2018
• Supplement Date Received by Manufacturer: 05/23/2018; 05/29/2018; 11/16/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 05/23/2018; 05/30/2018; 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1