MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FLEXIBLE PASSING PIN, 13.50 X 2.4MM; ACCESSORIES,ARTHROSCOPIC

Catalog Number 72201594

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/31/2017

Event Type  Injury  

Event Description

It was reported that one pin broke inside a patient and was not able to be retrieved.A backup device was drilled and case was completed.

Manufacturer Narrative

Examination was not possible, as the device was not returned.The investigation could not draw any conclusions about the reported event without the return of the device.No further medical assessment can be rendered at this time based on information provided.

• Brand Name: FLEXIBLE PASSING PIN, 13.50 X 2.4MM
• Type of Device: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 7014206
• MDR Text Key: 91480136
• Report Number: 1219602-2017-01372
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2022
• Device Catalogue Number: 72201594
• Device Lot Number: 50684454
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 01/30/2018
• Supplement Dates FDA Received: 02/06/2018
• Date Device Manufactured: 09/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other