MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG/COMP SCREW KIT 80/75; NAIL, FIXATION, BONE

Catalog Number	71677080
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Death (1802)
Date of Event	08/29/2017
Type of Reportable Event	Death
Event or Problem 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 natural death.
Additional 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: LAG/COMP SCREW KIT 80/75
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6926375
• Report Number: 1020279-2017-00835
• Device Sequence Number: 1443726
• Product Code: JDS
• UDI-Device Identifier: 03596010563286
• UDI-Public: 03596010563286
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K040212
• 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,Followup
• Report Date (Section B): 04/03/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 71677080
• Device Lot Number: 16KT76821
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 09/14/2017; 09/14/2017
• Initial Report FDA Received Date: 10/07/2017
• Supplement Report FDA Received Date: 10/12/2017; 04/03/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 88 YR