MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE; STAPLE, FIXATION, BONE

Model Number	72203290
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during surgery the osteoraptor gave of lots of metal debris when drilling anchor holes, all the metal was removed from the joint.The procedure was successfully completed using a back-up device.A delay of 5 minutes was reported.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: the reported 2.3 osteoraptor curved sa, intended for use in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the complaint was filed for shedding during drilling.This device has no drilling action associated with it.An exact root cause cannot be determined with confidence without the return of the devices in question.Per communication, all of the metal debris was removed from the joint using a shaver, a backup device was used to complete the procedure without a significant delay.No additional bone holes were needed.Since no patient harm is being alleged and no further harm is anticipated, no further clinical assessment is warranted at this time.

• Brand Name: OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9999638
• Report Number: 1219602-2020-00693
• Device Sequence Number: 3071089
• Product Code: JDR
• UDI-Device Identifier: 00885554022254
• UDI-Public: 00885554022254
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2023
• Device Model Number: 72203290
• Device Catalogue Number: 72203290
• Device Lot Number: 50742590
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1