MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG. INTERTAN 1.5 10MMX38CM 130D RT; NAIL, FIXATION, BONE

Model Number	71676536
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urticaria (2278)
Date of Event	02/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that smith & nephew implants that were put into patient during her femoral fracture surgery on (b)(6) 2018.Two weeks after surgery she experienced dry skin with a burning sensation on her thighs and feet.A few days later non-itchy, pain-free allergy like rashes began showing up on various parts of her body.They nearly disappear on application of aloe vera and allegra tablets.Her dermatologist diagnosed this as urticaria.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded that insufficient clinically relevant documentation was provided to perform a thorough medical investigation.The two photos submitted appear to demonstrate rash and/or hives on the upper left back/scapula area and an extremity.Without allergy testing results, pertinent medical history, and concomitant treatments/therapies a causal relationship cannot be confirmed.No further medical assessment is warranted at this time.Should additional information be provided, the clinical/medical task may be re-evaluated.The complaint later stated that two weeks after surgery the patient experienced dry skin with a burning sensation on her thighs and feet.A few days later non-itchy, pain-free allergy like rashes began showing up on various parts of her body.The condition nearly disappeared on application of aloe vera and allegra tablets.The patient¿s dermatologist diagnosed this as urticaria.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.Product was sterilized according to sterilization release documentation from quality control.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: INTERTAN 1.5 10MMX38CM 130D RT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS AG.; oberneuhofstrasse 10d; baar 06340 ; SZ 06340
• MDR Report Key: 8360005
• Report Number: 1020279-2019-00742
• Device Sequence Number: 183407
• Product Code: JDS
• UDI-Device Identifier: 00885556038017
• UDI-Public: 00885556038017
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2019

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: Health Professional
• Device Expiration Date: 01/19/2024
• Device Model Number: 71676536
• Device Catalogue Number: 71676536
• Device Lot Number: 14AM14199
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 11/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCREW PART# 71642235, BATCH # 17LM16562; SCREW PART # 71642240, BATCH# 17MM06409; SCREW PART # 71677095, BATCH # 16KT76666; SCREW PART# 71642235, BATCH # 17LM16562; SCREW PART # 71642240, BATCH# 17MM06409; SCREW PART # 71677095, BATCH # 16KT76666
• Outcome Attributed to Adverse Event: Required Intervention