MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF DEAD BLOW MALLET; ORTHOPAEDIC SURGICAL INSTRUMENT

Catalog Number 71362106

Device Problems Break (1069); Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/01/2015

Event Type  Injury  

Event Description

It was reported that the dead blow mallet broke and sand inside the mallet fell into the wound.

Manufacturer Narrative

(b)(4).No product was returned, hence visual or dimensional inspection could not be completed.No lot number was provided; hence dhr could not be completed.If more information is received, this investigation will be reopened.

Event Description

Further information received indicated surgeon irrigated the wound with copious amounts of antibiotic irrigation and covered the patient with post op antibiotics.

• Brand Name: REF DEAD BLOW MALLET
• Type of Device: ORTHOPAEDIC SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: robert rust ; 1450 brooks road; memphis, TN 38116 ; 9013991624
• MDR Report Key: 4949729
• MDR Text Key: 16955949
• Report Number: 1020279-2015-00511
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/08/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71362106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/08/2015
• Initial Date FDA Received: 07/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other