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

Model Number 72203290

Device Problem Flaked (1246)

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

Event Date 03/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event 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.

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
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9999638
• MDR Text Key: 188964875
• Report Number: 1219602-2020-00693
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00885554022254
• UDI-Public: 00885554022254
• Combination Product (y/n): N
• PMA/PMN Number: K151105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1