MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPATIAL FRAME SHOULDER BOLT; PIN, FIXATION, THREADED

Catalog Number	71070310
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bolt didn¿t fit into the strut as it normally does.The shoulder bolt broke and got stuck inside a strut.Delay no longer than 30 minutes was recorded.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the broken device goes on external fixation, not incurring to any risk that could fall into the incision, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: SPATIAL FRAME SHOULDER BOLT
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8512563
• Report Number: 1020279-2019-01532
• Device Sequence Number: 1465495
• Product Code: JDW
• UDI-Device Identifier: 03596010416407
• UDI-Public: 03596010416407
• Combination Product (Y/N): N
• PMA/510(K) Number: K994143
• 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): 04/22/2019

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 Catalogue Number: 71070310
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/14/2019
• Supplement Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1