MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK; STAPLE, FIXATION, BONE

Model Number	72201992
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anchor smashed as it was being pounded in.A backup device was available to complete the procedure following a short delay.No patient impact was reported.
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.A review of the device history record shows there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.

• Brand Name: OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7167442
• Report Number: 1219602-2018-00031
• Device Sequence Number: 1407708
• Product Code: JDR
• UDI-Device Identifier: 03596010615534
• UDI-Public: (01)03596010615534(17)210802(10)50611081
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K082215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2018

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: 08/02/2021
• Device Model Number: 72201992
• Device Catalogue Number: 72201992
• Device Lot Number: 50611081
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1