MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10MM X 20CM 125D; NAIL, FIXATION, BONE

Catalog Number 71675204

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 08/29/2017

Event Type  Death  

Event Description

It was reported that a patient had a hip breakage operation, 1 day after the operation patient died.Although patient report states it was a naturel death.

Manufacturer Narrative

The associated complaint devices were not returned for evaluation.On post op day one after a total hip arthroplasty, it was reported that the patient died due to natural causes.Additional clinical information related to this case has been requested but not provided.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history on the reported parts revealed no additional complaints for the listed batches.Without the patient¿s medical history, comorbidities, and other relevant medical information, the root cause of the patient¿s demise cannot be determined.Based on a review of the limited details provided with this case, a causal relationship between the device and the reported death cannot be established.If additional relevant supporting documents are received, this case can be re-evaluated.No further clinical assessment is warranted at this time.However, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: INTERTAN 10MM X 20CM 125D
• Type of Device: NAIL, FIXATION, BONE
• 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: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 6926338
• MDR Text Key: 88702446
• Report Number: 1020279-2017-00837
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 03596010565372
• UDI-Public: 03596010565372
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K040212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 71675204
• Device Lot Number: 17ET87233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 88 YR